Review the contaminants we assess as part of the Eurofins Infant Formula Product Certification program and the applicable maximum allowable limits (MALs) for common infant formula formats.
To support product safety and regulatory compliance, we monitor infant formula for a range of potential chemical contaminants that may be present from raw materials, processing, packaging, or the environment.
The tables below summarize the contaminants we assess and the applicable maximum allowable limits (MALs), where established, for common infant formula formats (powder and liquid/ready-to-feed). These limits help ensure contaminant levels remain within defined safety thresholds.
Disclaimer: The limits shown are the published limits as of May 1, 2026, and may be updated as regulations and guidance evolve.
| Analyte | Matrix | MAL |
| Elemental contaminants | ||
|---|---|---|
| Lead | Powder | 0.020 mg/kg |
| Liquid | 0.010 mg/kg | |
| Cadmium | Powder | 0.020 mg/kg for soy 0.010 mg/kg for all others |
| Liquid | 0.010 mg/kg for soy 0.005 mg/kg for all others |
|
| Nickel | Powder | 0.40 mg/kg for soy 0.25 mg/kg for all others |
| Liquid | 0.10 mg/kg | |
| Mercury | Powder | 0.010 mg/kg* |
| Liquid | ||
| Inorganic tin | RTF | 50 mg/kg |
| Inorganic arsenic | Powder | 0.020 mg/kg |
| Liquid | 0.010 mg/kg | |
| Mycotoxin contaminants | ||
| Aflatoxin M1 | Powder | 0.025 µg/kg* |
| Liquid | ||
| Process contaminants | ||
| Total 3-MCPD (3-MCPD and associated fatty acid esters) | Powder | 80 µg/kg |
| Liquid | 12 µg/kg | |
| Glycidyl fatty esters (GE) | Powder | 50 µg/kg |
| Liquid | 6.0 µg/kg | |
| Intentional adulterants | ||
| Melamine | Powder | 1.0 mg/kg |
| Liquid | 0.15 mg/kg | |
| Environmental/Industrial contaminants | ||
| Total dioxins | All | 0.1 pg WHO-PCDD/F-TEQ/g* |
| Total dioxins and dioxin-like PCBs | All | 0.2 pg WHO-PCDD/F-PCB-TEQ/g* |
| Total non-dioxin-like PCBs | All | 1.0 ng/g* |
| Perchlorate | All | 0.01 mg/kg* |
| PFAS | ||
| PFOS | All | 0.050 ug/kg* |
| PFOA | All | 0.050 ug/kg* |
| PFNA | All | 0.050 ug/kg* |
| PFHxS | All | 0.050 ug/kg* |
| PAH4: sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene, and chrysene | All | 1.0 µg/kg* |
| Benzo(a)pyrene | All | 1.0 µg/kg* |
| Total MOAH | Powder | 0.5 mg/kg* |
| Total MOSH | Powder | 1.0 µg/kg* |
| Liquid | 0.5 mg/kg* | |
| Bisphenol A (BPA)** | Powder | 2.0 mg/kg* |
| Liquid | 0.3 mg/kg | |
| Phthalates: BBP, DBP, DEHP, DIDP, DINP, DAP** | All | 0.01 mg/kg |
*Indicates level is applicable to formula as-fed
**No established safety limit exists for these substances; therefore, they are not considered permitted at any level. Maximum allowable levels indicated reflect method LOQs at the time of publication.
| Analyte | Reporting limit (mg/kg) | CAS# | Chemical name of the regulated substance | Maximum Residue Level (MRL) per day (mg/kg) |
| Aldrin | 0.002 | 309-00-2 | Total dieldrin (sum of aldrin and dieldrin) | 0.003 |
| Dieldrin | 0.002 | 60-57-1 | ||
| Cadusafos | 0.006 | 95465-99-9 | Cadusafos | 0.006 |
| Demeton-S-methyl | 0.002 | 919-86-8 | Total demeton (sum of demeton-S-methyl, demeton-S-methyl sulfone, oxydemeton-methyl) | 0.006 |
| Demeton-S-methyl sulfone | 0.002 | 17040-19-6 | ||
| Oxydemeton-methyl | 0.002 | 301-12-2 | ||
| Disulfoton | 0.001 | 298-04-4 | Total disulfoton (sum of disulfoton, disulfoton-sulfone, disulfoton-sulfoxide) | 0.003 |
| Disulfoton-sulfone | 0.001 | 2497-06-5 | ||
| Disulfoton-sulfoxide | 0.001 | 2497-07-6 | ||
| Endrin | 0.003 | 72-20-8 | Endrin | 0.003 |
| Ethoprophos | 0.008 | 13194-48-4 | Ethoprophos | 0.008 |
| Fensulfothion | 0.001 | 115-90-2 | Total fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones) | 0.003 |
| Fensulfothion oxon | 0.001 | 6552-21-2 | ||
| Fensulfothion oxon sulfone | 0.001 | 6132-17-8 | ||
| Fentin | 0.003 | 668-34-8 | Fentin | 0.003 |
| Fipronil | 0.002 | 120068-37-3 | Total fipronil (sum of fipronil and fipronil-desulfinyl) | 0.004 |
| Fipronil desulfinyl | 0.002 | 205650-65-3 | ||
| Glyphosate | 0.010 | 1071-83-6 | Glyphosate | 0.01 |
| Haloxyfop-methyl | 0.001 | 72619-32-0 | Total haloxyfop (sum of haloxyfop, its salts and esters including conjugates) | 0.003 |
| Heptachlor epoxide | 0.001 | 1024-57-3 | Total heptachlor (sum of heptachlor and trans-heptachlor epoxide) | 0.003 |
| Heptachlor trans-epoxide | 0.001 | 28044-83-9 | ||
| Hexachlorobenzene (HCB) | 0.003 | 118-74-1 | Hexachlorobenzene | 0.003 |
| Nitrofen | 0.003 | 1836-75-5 | Nitrofen | 0.003 |
| Omethoate | 0.003 | 1113-02-6 | Omethoate | 0.003 |
| Propineb | 0.003 | 12071-83-9 | Total propineb (sum of propineb and PTU) | 0.006 |
| Propylenethiourea (PTU) | 0.003 | 2122-19-2 | ||
| Terbufos | 0.001 | 112410-23-8 | Total terbufos (sum of terbufos, its sulfone and sulfoxide) | 0.003 |
| Terbufos sulfone | 0.001 | 22248-79-9 | ||
| Terbufos sulfoxide | 0.001 | 116-29-0 |
21 CFR § 106, Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications [1]
21 CFR § 107, Infant Formula [1]
21 CFR § 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food [1]
21 CFR § 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food [1]
21 CFR § 121, Mitigation Strategies to Protect Food Against Intentional Adulteration [1]
21 U.S.C. § 342.4, Adulterated Food
40 CFR § 141, National Primary Drinking Water Regulations
40 CFR § 455, Pesticide Chemicals
Commission Recommendation (EU) 2022/1431, Monitoring of perfluoroalkyl substances in food [4]
Commission Regulation (EU) No 10/2011 § Annex I, Plastic materials and articles intended to come into contact with food [4]
Commission Regulation (EU) 2016/127 § Annex IV, Specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding [4]
Commission Regulation (EU) 2023/915 § Annex I, Maximum levels for certain contaminants in food [4]
Draft Commission Recommendation amending Regulation (EU) 2023/915, Maximum levels of mineral oil aromatic hydrocarbons in food. [5]
Draft Commission Recommendation amending Regulation (EU) 2017/84, Monitoring of mineral oil hydrocarbons in food.
[1] U.S. Food and Drug Administration. 21 CFR 106.3 – Definitions. Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-106/section-106.3
[2] U.S. Environmental Protection Agency. 40 CFR Part 141 – National Primary Drinking Water Regulations. Code of Federal Regulations. https://www.ecfr.gov/current/title-40/chapter-I/subchapter-D/part-141
[3] U.S. Environmental Protection Agency. 40 CFR Part 455 – Pesticide Chemicals. Code of Federal Regulations. https://www.ecfr.gov/current/title-40/chapter-I/subchapter-N/part-455
[4] Official Journal of the European Union, Publications Office of the European Union. <https://eur-lex.europa.eu/oj/direct-access.html>
[5] European Commission. Draft Commission Regulation (EU) amending Regulation (EU) 2023/915 as regards maximum levels of mineral oil aromatic hydrocarbons in food. Official draft regulation. https://members.wto.org/crnattachments/2026/SPS/EEC/26_01382_00_e.pdf