An allergen list looks like the simplest line on a label, until three markets disagree on what belongs on it. A soy-based ingredient can be mandatory to declare in one country and merely recommended in another; a nut that was optional to flag two years ago can become mandatory next.
This guide compares Japan’s mandatory and recommended allergen lists with the EU’s and the US’s, explains cross-contact (“may contain”) wording, and sets out what a Japanese factory records so the claim on your label is defensible.
💬 Building an allergen statement for a Japan-made product sold in more than one market? We map your formula against all three lists before it goes to label. See Japan-made supplement OEM.
Japan’s mandatory and recommended allergens
Japan has 9 mandatory allergens (特定原材料) and 20 recommended items (特定原材料に準ずるもの), and the lists change as case data comes in.
| List | Status | Current items |
|---|---|---|
| Specified raw materials (特定原材料) | Mandatory on every processed food label | Egg, milk, wheat, buckwheat, peanut, shrimp, crab, walnut, cashew nut |
| Items equivalent to specified raw materials (特定原材料に準ずるもの) | Recommended, not mandatory | Almond, abalone, squid, salmon roe, orange, kiwi fruit, beef, sesame, salmon, mackerel, soybean, chicken, banana, pistachio, pork, macadamia nut, peach, yam, apple, gelatin |
Two recent changes matter for a specification written today. Walnut moved from the recommended list to the mandatory list, with the transition period ending 31 March 2025 — every processed food made, imported or sold in Japan from 1 April 2025 must declare walnut if it is present. Cashew nut followed the same path: the Consumer Affairs Agency (CAA) added it to the mandatory list, effective 1 April 2026, after case data showed tree-nut allergy overtaking wheat in Japan’s national allergy survey. Pistachio was added to the recommended list at the same time, and matsutake mushroom was removed from the recommended list in March 2024 in favour of macadamia nut. A specification written before these dates can be out of date; always confirm the current lists on caa.go.jp before finalising a label.
Gelatin and soybean sit on the recommended, not mandatory, list in Japan — a point worth checking against your own market, since both appear as mandatory allergens elsewhere (see below).
How the EU and the US compare
The EU and the US both name more or different allergens as mandatory than Japan does, so a formula cleared for the Japanese market can still need extra declarations abroad.
| Market | Mandatory allergen count | List | Legal basis |
|---|---|---|---|
| Japan | 9 | Egg, milk, wheat, buckwheat, peanut, shrimp, crab, walnut, cashew nut | Food Labelling Act / Food Labelling Standards, CAA |
| EU | 14 | Cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, tree nuts (almond, hazelnut, walnut, cashew, pecan, Brazil nut, pistachio, macadamia), celery, mustard, sesame seeds, sulphur dioxide/sulphites above 10 mg/kg, lupin, molluscs | Regulation (EU) No 1169/2011, Annex II |
| US | 9 | Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame | Food Allergen Labeling and Consumer Protection Act, as amended by the FASTER Act 2021 |
The gaps run both ways. Buckwheat, a Japanese mandatory allergen because of severe local reaction rates, has no equivalent mandatory status in the EU or US lists. Sesame became the ninth major US allergen only from 1 January 2023, under the FASTER Act signed 23 April 2021 — before that date it needed no separate US declaration. The EU’s soybean, celery, mustard, sulphites and lupin have no Japanese mandatory equivalent (soybean sits on Japan’s recommended list only). Gelatin is not a named allergen category in the EU or US lists at all; it is a Japanese recommended item because of documented reaction cases there.
💬 Selling the same Japan-made formula into the EU or the US? We build one allergen statement per market from the same production record, rather than guessing which list applies. Tell us your markets.
Cross-contact and “may contain” wording
Japan requires a factual statement about shared production lines and specifically prohibits “may contain” possibility wording.
| Wording style | Where it is used |
|---|---|
| ”This product is manufactured in a factory that also produces products containing [allergen].” | The only accepted form in Japan when a shared line or facility creates a contamination risk. Required to be a factual statement, not a possibility. |
| ”May contain [allergen]” / “may be present” | Explicitly not permitted in Japan, even outside the main ingredient panel. Common and voluntary in the EU and the US, where wording is not standardised by law. |
Japan’s Food Labelling Standards Q&A states that possibility expressions such as “may contain” or “there is a risk of containing” are not recognised for allergen labelling; a business must instead make a definite, factual statement about shared equipment or facilities, based on its own risk assessment. The EU and the US, by contrast, leave precautionary allergen labelling voluntary and unregulated in wording — a US “may contain” statement is not required by law and its phrasing is not standardised, provided it is truthful and not misleading.
What a Japanese factory documents
A Japanese GMP-certified factory records the allergen status of every raw material and the line-sharing history behind any cross-contact statement.
- Raw material declarations. Each incoming ingredient’s supplier declares whether it contains, or is produced on a line shared with, any of Japan’s mandatory or recommended allergens.
- Formula-level allergen matrix. The full recipe is checked against Japan’s mandatory list first, then against the recommended list and any additional allergen your export markets require.
- Line and changeover records. Where a shared line is used, the factory’s cleaning validation and production sequence support the wording used on the cross-contact statement.
- Country-specific label review. Because Japan, the EU and the US allergen lists differ, the same formula usually needs a separate allergen statement drafted for each destination market.
Before you ask for a quotation
- Full ingredient list, including any processing aid or carrier that might itself contain an allergen
- Every market the product will be sold in, since the mandatory list differs by market
- Whether any ingredient is produced on a shared line with a Japanese mandatory or recommended allergen
- Any allergen-free or “free from” claim you intend to make on pack
- First order and annual volume
💬 Ready to check your formula against Japan’s current allergen lists? Send us the full ingredient list and your markets and we return the allergen statement each label needs.
Frequently asked questions
1. How many allergens must be declared on a Japan-made supplement sold only in Japan?
Nine are mandatory: egg, milk, wheat, buckwheat, peanut, shrimp, crab, walnut and cashew nut (cashew became mandatory from 1 April 2026, with a transition period for label changes to 31 March 2028). A further 20 items, including soybean and gelatin, are recommended but not required.
2. Is soybean a mandatory allergen in Japan?
No. Soybean is on Japan’s recommended list, not the mandatory list — a gap worth checking if your export market treats soybean as mandatory, as the EU does.
3. Can I use “may contain traces of” on a Japan-made label?
Not for the Japanese market. Japan’s Food Labelling Standards Q&A rules out possibility wording; a shared-line risk must be stated as a fact, for example “this product is manufactured in a factory that also produces products containing [allergen].”
4. Is sesame a mandatory allergen in the US?
Yes, since 1 January 2023, when the FASTER Act’s addition of sesame as the ninth major US food allergen took effect. Before that date it was not separately regulated.
5. Why does a formula cleared for Japan sometimes need extra work for the EU?
The EU’s mandatory list has 14 categories against Japan’s 9, and includes celery, mustard, lupin, sulphites and soybean, none of which are mandatory in Japan. The formula itself may not change, but the label does.
Sources: Consumer Affairs Agency (Japan), Food Labelling Standards and Food Labelling Standards Q&A on allergen labelling, caa.go.jp; Yamanashi Prefecture, food labelling notice on the 1 April 2026 allergen list (特定原材料・特定原材料に準ずるもの), pref.yamanashi.jp; foodnavigator.com, “Japan moves to bolster food allergen controls after nut cases spike” (28 January 2026); Regulation (EU) No 1169/2011 on the provision of food information to consumers, Annex II, eur-lex.europa.eu; US Food and Drug Administration and FASTER Act of 2021 summaries confirming sesame as the ninth major allergen effective 1 January 2023, fda.gov / foodsafety.gov. Checked on 25 September 2026.