Heavy metals in food databaseFoods for infantsChecked 2026.10.03
Infant formula: lead, arsenic
In a MAFF survey (fiscal 2023), lead in 20 samples of powdered infant formula was at most 0.015 mg/kg (per powder), and the estimate after mixing with water was 0.0004–0.0010 mg/L. For 10 samples of liquid formula, lead and cadmium were below the limit of quantification in every sample. What started heavy metal regulation in Japan was the 1955 Morinaga arsenic milk poisoning.
Levels measured in Japanese government surveys and studies
| Metal | Form / state | Mean | Range / max | Samples | Survey |
|---|---|---|---|---|---|
| Lead | Total lead, formula (powder, per powder) | 0.003–0.007 | max 0.015 | 20 samples (14 below the limit of quantification) | MAFF, fiscal 2023 |
| Lead | Total lead, formula (powder, estimate after mixing, mg/L) | 0.0004–0.0010 | — | 20 samples | MAFF, fiscal 2023 |
| Lead | Total lead, formula (liquid) | 0–0.003 | all samples below the limit of quantification | 10 samples | MAFF, fiscal 2023 |
| Arsenic | Inorganic arsenic, formula (powder, per powder) | 0.007–0.013 | max 0.047 | 20 samples (13 below the limit of quantification) | MAFF, fiscal 2023 |
| Arsenic | Inorganic arsenic, formula (powder, estimate after mixing, mg/L) | 0.0010–0.0017 | — | 20 samples | MAFF, fiscal 2023 |
| Arsenic | Inorganic arsenic, formula (liquid) | 0.002–0.004 | max 0.004 | 10 samples (6 below the limit of quantification) | MAFF, fiscal 2023 |
| Arsenic | Total arsenic, formula (powder, per powder) | 0.014–0.018 (median 0.011) | max 0.069 | 20 samples (8 below the limit of quantification) | MAFF, fiscal 2023 |
| Cadmium | Total cadmium, formula (powder, per powder) | 0.004–0.008 | max 0.013 | 20 samples (13 below the limit of quantification) | MAFF, fiscal 2023 |
Units are mg/kg (= ppm). The “estimate after mixing” is the powder concentration divided by the dilution ratio written on each product (mg/L). Averages are given as a range, “the value with samples below the limit of quantification counted as 0 to the value with them counted at the limit of quantification.” This survey does not judge compliance with the Food Sanitation Act’s standards and specifications, and its analytical method also differs from the statutory method.
Limits (Japan, international, EU)
| Set by | Limit | Note |
|---|---|---|
| Japan (Food Sanitation Act) | Standards for lead and arsenic in formula: could not be confirmed in this survey | I did not check the individual provisions of the Ministerial Ordinance on Milk and Milk Products (unconfirmed). MAFF’s survey results cannot be used to judge compliance with standards |
| Codex (international standards) | Lead, infant formula 0.01 | — |
| EU (Regulation 2023/915) | Lead 0.020 (powder) / 0.010 (liquid), inorganic arsenic 0.020 (powder) / 0.010 (liquid), cadmium 0.010 (powder) to 0.020 (soy) | These cannot be compared directly with Japan’s survey values, because the analytical methods and purpose of the survey differ |
| US (FDA) | Not covered by the lead action levels | The January 2025 guidance does not include infant formula, beverages, or juice |
Good to know
- For powdered formula, lead was below the limit of quantification (0.006) in 14 of 20 samples, with a maximum of 0.015 mg/kg. The estimate after mixing averaged 0.0004–0.0010 mg/L. In the same survey, inorganic arsenic was at most 0.047 in the powder, and the estimate after mixing averaged 0.0010–0.0017 mg/L.
- For liquid formula, lead and cadmium were below the limit of quantification in all 10 samples, and inorganic arsenic was at most 0.004 mg/kg.
- The Morinaga arsenic milk poisoning (1955): the dibasic sodium phosphate added to powdered milk at the Tokushima factory was contaminated with about 10% inorganic arsenic. About 12,000 infants were poisoned and 133 died, according to the FSCJ (worded as “is said to be”).
- The figures for the incident differ by source. Deaths are given as 130, 131, or 133 and victims as 12,000–12,159 depending on the source, and the original source (the announcement by the then Ministry of Health and Welfare) could not be confirmed. There are also different analyses of the follow-up (5,064 people in Tanaka & Oshima 2007, 6,104 people in an FSCJ document), so care is needed not to mix the numbers.
- The incident led to the establishment on December 28, 1959 of the standards and specifications for food additives and others (Ministry of Health and Welfare Notification No. 370), which began arsenic regulation in Japan.
- The lead and arsenic in the water used for mixing are covered by the tap water quality standards (both 0.01 mg/L or less). See also the section on tap water and mineral water.
Related explainers
- Heavy Metals in Baby Food, Infant Food, and Powdered Formula: MAFF’s Survey and Standards Abroad
- Why Do Heavy Metal Standards Differ Between Japan and Other Countries? Japanese, Codex, and EU Standards and Tolerable Intakes Compared
- Lead: Tap Water, Tableware, Cans, and Spices. Where Should You Be Careful? Lead in Food, and Entry Points Other Than Food
Pages for each metal
Sources
- MAFF, “Results of the fiscal 2023 survey of lead and other contents in foods for infants and toddlers” (published December 2024)
- FSCJ, “Food health impact assessment: arsenic” (December 2013. Account of the Morinaga arsenic milk poisoning)
- Tanaka & Oshima. 2007 (follow-up study of the Morinaga arsenic milk poisoning)（PMID 17533959）
- EU Regulation 2023/915 (maximum levels for contaminants in food)
- US FDA, “Action levels for lead in processed food intended for babies and young children (final guidance)” (January 2025)
- MAFF, “Lead standards set by international organizations and other countries”
- Ordinance on water quality standards (e-Gov Law Search)
Last checked 2026.10.03 (against the original government documents and papers, collected and cross-checked in Gemini Notebook).
Heavy metals occur naturally in soil and the sea, and every food contains small amounts. This page lists facts from government surveys, limits and assessments and from published papers; it does not judge any food as good or bad. Where there is official advice — such as on eating fish during pregnancy — follow it.