Infant Formula Chemical Contaminants and Maximum Allowable Limits

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.

<< Back to Eurofins Infant Formula Product Certification

Table 6.1 Chemical Contaminants and their limits in infant formula

Analyte	Matrix	MAL
Elemental contaminants
Lead	powder	0.020 mg/kg
Lead	liquid	0.010 mg/kg
Cadmium	powder	0.020 mg/kg for soy 0.010 mg/kg for all others
Cadmium	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
Nickel	liquid	0.10 mg/kg
Mercury	powder	0.010 mg/kg*
Mercury	RTF	0.010 mg/kg*
inorganic tin	liquid	50 mg/kg
inorganic arsenic	powder	0.020 mg/kg
inorganic arsenic	liquid	0.010 mg/kg
Mycotoxin contaminants
aflatoxin M1	powder	0.025 µg/kg*
aflatoxin M1	liquid	0.025 µg/kg*
Process contaminants
total 3-MCPD (3-MCPD and associated fatty acid esters)	powder	80 µg/kg
total 3-MCPD (3-MCPD and associated fatty acid esters)	liquid	12 µg/kg
glycidyl fatty esters (GE)	powder	50 µg/kg
glycidyl fatty esters (GE)	liquid	6.0 µg/kg
Intentional adulterants
Melamine	powder	1.0 mg/kg
Melamine	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 mg/kg
total MOSH	liquid	5.0 mg/kg
bisphenol A (BPA)**	powder	2.0 mg/kg*
bisphenol A (BPA)**	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.

Table 6.2 Pesticides and their limits in infant formula

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	total dieldrin (sum of aldrin and dieldrin)	0.003
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		0.004
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		0.003
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	total propineb (sum of propineb and PTU)	0.006
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 Formula¹

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