EU Import Requirements Overview for Japan-Origin Products

EU cosmetics: CPNP notification and the Responsible Person

The EU Cosmetic Products Regulation requires that every cosmetic product placed on the EU market be notified to the Cosmetic Products Notification Portal (CPNP) before the first placing on the market. Three structural points overseas buyers should understand:

• The Responsible Person (RP) is the entity legally accountable. The RP must be established in the EU. A Japanese manufacturer cannot itself be the RP; a foreign brand owner cannot itself be the RP unless it establishes an EU entity or appoints an EU-based RP service.
• The RP holds the Product Information File (PIF).The PIF includes the product description, safety assessment (Cosmetic Product Safety Report, CPSR) prepared by a qualified safety assessor, method of manufacture in line with EU GMP, claims substantiation, and animal testing declarations. The PIF must be made available to the competent authority within a short period on request.
• The CPNP notification is by product, not by batch. Once a product is notified, batches can be placed on the market without further per-batch filings, so long as the formulation does not change.

For Japanese OEM cosmetics, the practical path for a foreign brand owner is typically one of: (a) appoint an EU-based RP service provider; (b) establish an EU subsidiary that becomes the RP; or (c) use the EU subsidiary of a distributor that already has the necessary infrastructure.

EU food and supplements: FIC labelling and supplement directives

Regulation (EU) 1169/2011 (Food Information for Consumers, FIC) sets out the mandatory labelling content for food sold in the EU, including supplements. Key points for Japan-origin products:

• Mandatory particulars. Name of the food, list of ingredients in descending order by weight, allergen declaration (highlighted in the ingredient list), quantitative ingredient declaration where applicable, net quantity, date marking (use-by or best-before), storage and use conditions, name and address of the food business operator responsible, country of origin where required, instructions for use, and the nutrition declaration.
• Allergen declaration.14 allergens listed in Annex II must be highlighted in the ingredient list (typically by bold typeface). The list differs from Japan's allergen list — confirm allergen content with the Japanese OEM manufacturer at recipe stage.
• Language. The mandatory information must be in a language easily understood by the consumer in the member state where the food is marketed. In practice this means the official language(s) of that member state.
• Food supplements. Directive 2002/46/EC sets common rules for supplements; member states may set additional national rules (e.g., maximum vitamin and mineral levels). The list of permitted vitamins, minerals, and their chemical forms is harmonised at EU level.
• Health and nutrition claims. Regulation (EC) 1924/2006 governs claims. Only authorised claims may be made; the EU Register of authorised claims is the reference source.

Novel food authorisation

Regulation (EU) 2015/2283 requires that food and food ingredients that were not used to a significant degree for human consumption in the EU before 15 May 1997 be authorised as novel food before being placed on the EU market. This matters for Japan-origin supplements and functional food ingredients — Japanese fermentation-derived ingredients, certain algal extracts, certain plant extracts not historically consumed in the EU, and some traditional Japanese ingredients with no EU history are in scope.

Two routes:

• Full novel food authorisation. Application to the European Commission with safety dossier evaluated by EFSA. Typically 18–36 months.
• Traditional food from a third country notification.Lighter procedure for ingredients with a documented 25-year history of safe use outside the EU. Notification to the European Commission with simplified evidence. Typically 6–12 months.

Check the EU Novel Food Catalogue and the Union list of authorised novel foods before committing to a Japanese ingredient that has no obvious EU history.

EU customs: EORI, classification, and VAT

• EORI number. The importer of record must hold an EU EORI number. The Japanese OEM manufacturer is not the importer of record; the EU-based importer is. For brands without an EU entity, the EU-based distributor or fulfilment partner typically acts as importer.
• CN code classification. The 8-digit Combined Nomenclature is used for import declarations. Duty rates and some restrictions depend on the CN code. Same first 6 digits as the WCO HS code; EU-specific extensions in the 7th and 8th digits.
• EU–Japan Economic Partnership Agreement (JEEPA).Provides preferential tariff treatment for most Japan-origin goods. Origin can be self-declared by an exporter registered in the REX system, or supported by a Statement on Origin from the Japanese exporter. Apply at the time of import declaration.
• VAT. Import VAT is paid at the time of importation by the importer of record, then deductible against output VAT once the goods are sold. Distance-selling and One-Stop-Shop (OSS) schemes apply to direct-to-consumer sales.

Practical sequencing for Japan-origin EU launch

1. Confirm whether the product's ingredients are in scope of novel food authorisation. Resolve any novel-food gap before designing the formulation.
2. For cosmetics: confirm RP arrangement, commission the CPSR, and build the PIF. For food: design the label content including the allergen declaration, country of origin, and quantitative ingredient declaration.
3. Apply for the JEEPA preferential origin certification mechanism on the Japanese side ahead of first shipment.
4. Submit CPNP notification (cosmetics) or finalise label artwork (food) — both in parallel with first production at the Japanese OEM factory.
5. On arrival, the EU importer files the customs declaration, pays VAT, and the goods are released.
6. Post-market: maintain the PIF, log adverse events, coordinate any recalls with the RP, and update the CPNP notification on any formulation change.