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# Japan Food Contact Materials: What Hardware Makers Must Know About the Food Sanitation Act Standards

Japan's Food Sanitation Act (食品衛生法, Shokuhin Eisei Hō — Act No. 233 of 1947, substantially amended in 2018) and the accompanying Standards and Criteria for Food and Food Additives (厚生労働省告示第370号) set specific material standards for items that come into contact with food. Hardware products that touch food — kitchen appliances, food processing machinery, food storage containers, vending machine components, restaurant equipment — must comply with these material-specific standards for metals, plastics, rubber, and coatings. The Ministry of Health, Labour and Welfare (MHLW) and local health authorities enforce these standards, and non-compliant products can be seized at the border or recalled from the market. Japan's food contact material standards differ from EU Regulation 10/2011 and US FDA 21 CFR in some requirements — products compliant in one jurisdiction are not automatically compliant in Japan.

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At a glance

Governing law

Food Sanitation Act (Act No. 233 of 1947)

Administering body

MHLW + prefectural health departments

Standards reference

MHLW Notification No. 370

Key difference vs EU

Polymer-by-polymer (not positive list)

## Material-specific requirements under MHLW Standards

### What the Food Sanitation Act covers for hardware

The Act applies to 'cooking utensils, containers and packaging materials' (器具, 容器包装) — a broad category that includes any item that contacts food during processing, preparation, storage, or serving. Hardware products in scope include food processing machines, commercial kitchen equipment, food dispensers, vending machine food-contact surfaces, cookware, storage vessels, and the interior surfaces of refrigerators that contact food directly.

### Metal standards: stainless steel, tin, and lead limits

MHLW Standards specify migration limits for metals in food-contact applications. Stainless steel food-contact surfaces must meet specific composition and finish requirements. Tin-coated steel (for cans and some food processing equipment) has a migration limit of 150 ppm for tin. Lead content limits are strict — below 100 mg/kg for general food contact materials and stricter for children's products. Cadmium, arsenic, and antimony also have migration limits set in the Standards.

### Plastics standards: specific polymer requirements

Unlike EU Regulation 10/2011 (which takes a positive list approach for all plastic food contact materials), Japan's Standards set requirements polymer by polymer. Polyethylene (PE), polypropylene (PP), polystyrene (PS), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), and polyethylene terephthalate (PET) each have their own composition and migration test requirements in the Standards. A plastic not specifically listed in the Standards is not automatically permitted — hardware using novel polymer formulations must seek guidance from MHLW or local health authorities.

### Rubber and silicone

Rubber components in food-contact hardware — gaskets, seals, tubing — must meet MHLW standards for rubber food-contact materials. Migration tests for specific substances (phenolic antioxidants, vulcanisation agents) apply. Silicone rubber used in food-contact applications must meet the Standards' silicone-specific criteria, which differ from US FDA 21 CFR 177.2600 in some additive restrictions.

### Coating and lacquer requirements

Coatings applied to food-contact surfaces — non-stick coatings, epoxy lacquers, polyurethane coatings — are subject to migration testing requirements under the Standards. PFAS-based non-stick coatings (PTFE, for example) are assessed against migration limits for fluorinated compounds. Japan has been progressively reviewing PFAS food contact allowances following international regulatory pressure.

## How to assess and document food contact compliance for Japan

01

Identify all food-contact surfaces in your hardware product — surfaces that directly contact food during normal use. Prepare a bill of materials for food-contact components specifying polymer type, metal alloy, coating composition, and any additives.

02

Map each food-contact material against the relevant MHLW Standards category. For plastics, identify the specific polymer type and locate the applicable Standards requirements. For metals, determine alloy composition and applicable migration limits.

03

Commission migration testing in an accredited Japanese food testing laboratory if required — or obtain migration test data to MHLW Standards (which may differ from EU 10/2011 or US FDA test methods). Retain test certificates as part of the product's compliance documentation.

04

Prepare a declaration or technical statement confirming food-contact material compliance with MHLW Standards for your Japanese importer or distributor. While Japan does not have a formal food-contact declaration equivalent to the EU's Declaration of Compliance, importers and major retail buyers increasingly request documented material compliance evidence.

05

Monitor MHLW updates — Japan's food-contact standards are periodically revised, particularly as PFAS and other substance assessments progress. The MHLW website (mhlw.go.jp) publishes notifications of standards amendments. Significant changes may require re-testing.

## Frequently asked questions

### If my product is EU food contact compliant (EU Regulation 10/2011), is it automatically compliant in Japan?

No — Japan and the EU use different standard frameworks with different test methods and substance lists. EU compliance is useful as an indication of general material safety and provides testing data that may partially support Japan compliance, but specific MHLW Standard requirements must be verified separately. Japan does not have an equivalence recognition framework for EU food contact compliance.

### Who enforces food contact material standards in Japan for imported hardware?

Japan Customs cooperates with MHLW and local health authorities to inspect food-contact products at the border. The Ministry of Health, Labour and Welfare sets the standards; prefectural (ken) and city health departments enforce them at the market level. Inspections are conducted on imported products and products in trade — non-compliant products can be detained at the border, subject to recall, and the importer can face penalties under the Food Sanitation Act.

### Does a commercial kitchen appliance require Japanese PSE certification AND food contact material compliance?

Yes — for an electrically powered commercial kitchen appliance, both apply and neither substitutes for the other. PSE certification covers electrical safety (METI's jurisdiction under DENAN). Food contact material compliance covers material safety (MHLW's jurisdiction under the Food Sanitation Act). Both are required before commercial sale in Japan.

### What are the penalties for selling food-contact hardware that fails Japanese food safety standards?

Under the Food Sanitation Act, MHLW or prefectural health authorities can issue an order to suspend sales, recall products, and submit reports. Criminal penalties for deliberate violations include imprisonment of up to 3 years and fines up to JPY 2 million. Reputational damage from a Japanese market recall — which is publicly listed on MHLW's recall notices website — is typically more commercially damaging than the direct penalty.

**Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions.

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