Astolfi et al. 2021 — Italian Powdered Infant Formula Elements
Summary
This study measured 40 elements in 11 powdered infant formulas authorized and sold in Italy, using two packs of each product for 22 packs total, and assessed intake for selected metals. It is useful for Category 1 because it provides a focused powdered-formula dataset under an EU regulatory context.
Key numbers
- The study collected two packs of each available powdered product for 22 packs total.
- Be, B, Al, Zr, Nb, Sb, Te, W, V, Cr, and As were below the limit of detection in more than 30 percent of samples.
- Cd, Mn, Ni, Pb, and Zn concentrations in the formulas studied were reported as always below the considered limits.
- From the pasted risk-assessment table, the average concentration implied by the intake calculation is approximately Ni 0.0618 ug/g, Cd 0.0020 ug/g, and Pb 0.0020 ug/g; the highest formula-level means reported in the text were Ni 0.098 ug/g, Cd 0.0062 ug/g, and Pb 0.0028 ug/g.
Category 1 concentration rows
Values are for powdered formula as sold unless otherwise noted. Since the paper does not separate soy from non-soy products in the pasted text, these rows are broad powdered-formula context and should not be used as soy-specific or non-soy-specific p90 evidence.
| Evidence item | Category 1 fit | N | Basis | Reported value | Approximate ppb equivalent | Row-fit note |
|---|---|---|---|---|---|---|
| Nickel mean implied by intake table | infant-formula-powder | 11 formulas; 22 packs | powder as sold | approximately 0.0618 ug/g | 61.8 ppb | Mean reconstructed from Table 7 intake math; no benchmark percentile calculated from this source summary. |
| Nickel highest formula mean | infant-formula-powder | 11 formulas; 22 packs | powder as sold | 0.098 ug/g | 98 ppb | Highest formula-level mean reported for formula 2; no benchmark percentile calculated from this source summary. |
| Cadmium mean implied by intake table | infant-formula-powder | 11 formulas; 22 packs | powder as sold | approximately 0.0020 ug/g | 2 ppb | Mean reconstructed from Table 7 intake math; no benchmark percentile calculated from this source summary. |
| Cadmium highest formula mean | infant-formula-powder | 11 formulas; 22 packs | powder as sold | 0.0062 ug/g | 6.2 ppb | Highest formula-level mean reported for formula 8; no benchmark percentile calculated from this source summary. |
| Lead mean implied by intake table | infant-formula-powder | 11 formulas; 22 packs | powder as sold | approximately 0.0020 ug/g | 2 ppb | Mean reconstructed from Table 7 intake math; no benchmark percentile calculated from this source summary. |
| Lead highest formula mean | infant-formula-powder | 11 formulas; 22 packs | powder as sold | 0.0028 ug/g | 2.8 ppb | Highest formula-level mean reported for formula 8; no benchmark percentile calculated from this source summary. |
| Tin formula means | infant-formula-powder | 11 formulas; 22 packs | powder as sold | formula mean range about 0.0003 to 0.0969 ug/g | about 0.3 to 96.9 ppb | Calculated from Table 4 formula-level means; no benchmark percentile calculated from this source summary. |
| Aluminum, total arsenic, total chromium | infant-formula-powder detection context | 11 formulas; 22 packs | powder as sold | excluded from subsequent analysis because >30 percent of values were below LOD | not summarized | Detection-limit context only; not an occurrence distribution. |
Intake and risk rows
The paper estimates intake for nickel, zinc, cadmium, and lead from birth through six months. The highest percentage health risk index in the pasted table is for nickel at 57.1 percent of the EFSA nickel daily limit for females aged 0-2 weeks; cadmium remains below 15 percent of the EFSA cadmium weekly limit, lead below about 10.2 percent of the cited lead weekly value, and zinc around 5 percent of the zinc upper limit.
Methods (brief)
The study used ICP-MS for multi-element analysis of powdered infant formulas. The sampling frame was the Italian Ministry of Health national register for formulas authorized at the time of the study.
Limitations
The source is powdered-formula specific and does not cover ready-to-feed formula, soy-specific formula rows, or other infant food categories. The pasted text does not identify individual product labels or soy status, so row fit remains broad powdered formula. Values reconstructed from intake tables should be treated as derived source-backed summaries, not directly reported p90 data.
Implications
Certification: Useful A-tier EU-context evidence for powdered infant formula and non-detect handling.
Courses: Useful example of targeted formula sampling from a regulatory product register.
App: Supports powdered formula risk estimation and EU jurisdiction comparison.
Microbiome: No direct microbiome endpoint.