Japan has long been associated in Europe with quality, precision and a culture of longevity — associations that translate exceptionally well into the functional food and food supplement categories. The EU–Japan Economic Partnership Agreement has further facilitated trade by eliminating or reducing tariffs on most goods. All of this means that an increasing number of businesses are considering bringing Japanese food products to the EU market. What is crucial to understand, however, is that origin from a country with high standards does not exempt a product from the obligation to meet European standards.

The starting point is Regulation (EC) No 178/2002, which establishes the general principles of food law. It introduces a fundamental rule: food placed on the EU market must be safe, and responsibility for this rests with the operator acting within the EU — typically the importer. It is the importer, not the Japanese manufacturer, who is accountable to the authorities for the product's compliance with the law. This principle shapes everything that follows: the importer must know precisely what they are bringing in, what it is made of, and whether it may lawfully be sold in Europe in that form.

Radiation Controls — A Chapter Now Closed

For over a decade, importing food from Japan involved additional radiation controls introduced following the Fukushima nuclear accident in 2011. These required certificates and testing for radionuclides for certain product categories. It is worth noting that this chapter has been formally closed: by Implementing Regulation (EU) 2023/1453, the European Commission repealed those specific requirements with effect from 3 August 2023. This means that Japanese food is no longer subject to EU radiation controls or to any obligation to attach radiation certificates. This is a significant simplification — though it does not remove any of the other requirements described below.

Novel Food — The Most Common Pitfall

This is where most Japanese projects come unstuck. Regulation (EU) 2015/2283 on novel food provides that any ingredient not consumed to a significant degree in the Union before 15 May 1997 requires prior authorisation before it may be lawfully placed on the market. The problem is that many ingredients popular in Japan have a long history of consumption there — but not in Europe. From an EU perspective they remain "novel", regardless of how long they have been on the Asian market.

This applies to a wide range of fashionable ingredients: certain postbiotics and metabiotics, exotic botanical extracts, selected forms of fucoidan (authorisation covers specific algal sources and intake limits), and molecules positioned around the longevity theme, such as NMN — which is not yet authorised in the EU as a novel food (despite a positive EFSA safety opinion issued in May 2026 proposing a level of approximately 300 mg/day, European Commission authorisation is still pending). This is even more apparent with products based on the latest technologies, such as drinks containing exosomes or polynucleotides, which in their current form have virtually no pathway to market without their own authorisation.

Expert Tip: In practice, the same product may have been sold in Japan for years while requiring a multi-year authorisation procedure in the EU — or may simply be inadmissible. Novel food status is assessed for a specific ingredient and its source; a trade name settles nothing. The first step with any Japanese portfolio should therefore be screening the ingredient lists for novel food status, before investing in label translations or logistics.
flowchart TD
    A[Product from Japan] --> B{Contains novel\nfood ingredient?}
    B -->|Yes| C{Authorised in EU?}
    B -->|No| D{Supplement or\nordinary food?}
    C -->|Yes| D
    C -->|No| E[STOP: Novel Food\nauthorisation required]
    D -->|Food supplement| F{Animal origin?}
    D -->|Ordinary food| G{Animal origin?}
    F -->|Yes| H[Veterinary control\n+ supplement notification]
    F -->|No| I[Supplement notification\nin Member State]
    G -->|Yes| J[Approved establishment\n+ TRACES + CHED-P]
    G -->|No| K[Standard\ncustoms clearance]
Decision flowchart: the classification of a product from Japan determines its import pathway into the EU.

Food Supplements — National Frameworks Still Diverge

If a product qualifies as a food supplement, it falls within the scope of Directive 2002/46/EC. This harmonises the lists of permitted vitamins and minerals and their chemical forms, but many issues — above all maximum levels and the admissibility of botanical ingredients — remain a matter for individual Member States. As a result, the same Japanese supplement may be lawful in one EU country yet exceed the national limit in another, or contain a plant that appears on a national list of prohibited or restricted ingredients. It is therefore more prudent to select one or two entry markets and adapt the product accordingly, rather than assuming uniformity across the Union.

Products of Animal Origin — A Separate Border Pathway

A significant portion of Japan's health product offering is based on marine and animal raw materials: fish collagen, squalene and fish oils. This triggers a separate regime of veterinary controls. Importing such products from Japan requires that they originate from establishments approved for export to the EU, that they are accompanied by the appropriate official certificates, and that the consignment has been pre-notified in the TRACES system and introduced through a designated border control post (CHED-P document). This is an entirely different channel from purely botanical or vitamin products, which pass through standard customs procedures.

flowchart LR
    subgraph SUP[Supplement Pathway]
        direction TB
        S1[Ingredient verification] --> S2[Notification in\nMember State]
        S2 --> S3[National supplement\nauthority]
        S3 --> S4[Label + claims\nper Reg. 1924/2006]
    end
    subgraph ZW[Animal-Origin Pathway]
        direction TB
        Z1[Approved establishment\nin Japan] --> Z2[Official certificate]
        Z2 --> Z3[TRACES notification\n+ CHED-P document]
        Z3 --> Z4[Border control\npost BCP]
    end
    A[Product from Japan] --> SUP
    A --> ZW
Pathway comparison: supplements go through national notification; animal-origin products go through veterinary border controls.

Contaminants, Additives and Hygiene

Regardless of category, all food must comply with EU requirements on maximum contaminant levels, permitted additives and production hygiene. This is an area where Japanese and European standards can diverge: a colourant or preservative routinely used in Japan may not appear on the EU list of permitted substances, and limits for certain heavy metals or other contaminants are sometimes set differently — and more strictly — in the EU. Verifying the composition from this angle is just as important as assessing novel food status, and it is precisely here that the most surprises tend to emerge when analysing real formulations.

Labelling and Claims — Where the Editorial Work Begins

Regulation (EU) No 1169/2011 sets out the mandatory information that must appear on a label: the name, list of ingredients, allergens, nutritional values, details of the responsible operator, storage conditions and much more — all in a language readily understood by consumers in the relevant Member State. A Japanese label, however carefully prepared, will almost never meet these requirements as it stands; it requires a complete rebuild, not merely a translation.

A separate and frequently underestimated challenge concerns claims. Regulation (EC) No 1924/2006 permits only nutrition and health claims that appear on approved lists, and at the same time absolutely prohibits attributing to food the properties of treating or preventing disease. Japanese health marketing, however, can be considerably bolder — product names or categories suggesting "calorie blocking", "cancer protection" or the prevention of specific conditions are simply not sustainable in the EU legal environment and must be rewritten before the product reaches the market.

Customs Duties and Logistics — Some Good News Here

Against the backdrop of the requirements above, customs matters are comparatively favourable. Thanks to the EU–Japan Economic Partnership Agreement, most goods of Japanese origin benefit — with a valid proof of origin — from preferential tariff treatment, often at a zero duty rate, which materially improves the economics of importing. VAT and the customs clearance procedure depend on the tariff classification of the product (CN code), so establishing this correctly at an early stage removes most of the uncertainty at the border.

It must be remembered, however, that the tariff preference applies solely to customs duties — it does not exempt products from any of the sanitary or veterinary (SPS) requirements described above. A zero duty rate will not get a non-compliant product through the border.

Conclusions

Bringing Japanese food products to the EU market is entirely feasible — provided it is treated as a regulatory project, not merely a logistical one. A significant portion of a typical Japanese portfolio (collagen peptides, isoflavones, omega-3s, liposomal vitamin C) has a comparatively straightforward path to market — though even these "easier" products usually require label adaptation and claims review, confirmation that the specific chemical form of a vitamin or mineral is permitted, and verification of the limits applicable in the chosen national market.

The flagship products, built around innovative ingredients, are typically the problematic ones, and it is precisely these that require an early, clear-eyed assessment. The best investment at the outset is a thorough screening of the entire range for novel food status and permitted ingredient levels — because that is what determines what can be sold immediately, what requires reformulation, and what simply cannot be placed on the market at all.

Disclaimer: Tomasz Krawczyk — legal counsel specialising in EU and Polish food law and food supplement regulation. supplemental.pl · foodlaw.ai. This material is for general information purposes only and does not constitute legal advice in any individual case.

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Frequently Asked Questions

Is Japanese food still subject to radiation controls in the EU?

No. By Implementing Regulation (EU) 2023/1453, the European Commission repealed those requirements with effect from 3 August 2023. Japanese food no longer requires radiation certificates when imported into the EU.

What is novel food status and why does it block Japanese products?

Regulation (EU) 2015/2283 provides that any ingredient without a history of consumption in the EU before 15 May 1997 requires European Commission authorisation. Many ingredients popular in Japan have no such history in Europe.

Does the EU–Japan EPA agreement exempt products from sanitary requirements?

No. The agreement covers tariff preferences (often a zero duty rate) but does not exempt products from sanitary, veterinary or phytosanitary (SPS) requirements.

Which products from Japan require veterinary border controls?

Products of animal origin: fish collagen, squalene and fish oils. They require establishment approval, official certificates, TRACES notification and a CHED-P document.

Can a Japanese food supplement be sold across the entire EU on a single notification?

Not in practice. Maximum levels and the admissibility of botanical ingredients differ between Member States.

Where should I start when analysing a Japanese product portfolio?

By screening the ingredient lists for novel food status. This determines what can be sold immediately, what requires reformulation, and what cannot be placed on the market at all.