Codex Limits For Lead and Arsenic: HTMC Benefits Original paper

Researched by:

  • Dr. Umar Aitsaam ID
    Dr. Umar Aitsaam

    User avatarClinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting.

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October 30, 2025

Researched by:

  • Dr. Umar Aitsaam ID
    Dr. Umar Aitsaam

    User avatarClinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting.

    Read More

Last Updated: 2025-10-30

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Dr. Umar Aitsaam

Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting.

What was reviewed?

This news release reviews decisions of the Codex Alimentarius Commission, jointly run by FAO and WHO, setting global food safety benchmarks, with emphasis on new maximum levels for lead in infant formula and arsenic in rice. The update centers on Codex limits for lead and arsenic, establishing 0.01 mg/kg lead in infant formula “as consumed” and 0.2 mg/kg inorganic arsenic in rice, alongside related measures on veterinary drugs, pesticide residues, fumonisins, and future standard-setting work. For HTMC, the article clarifies how Codex limits for lead and arsenic become foundational reference points for national regulation and trade, and signals where compliance codes of practice will guide agricultural and manufacturing controls to prevent contamination.

Who was reviewed?

Stakeholders include 170 countries, the European Union, and 30 international governmental and non-governmental organizations participating in the Codex session; food sectors affected are infant nutrition manufacturers and rice producers, especially in regions with arsenic-prone groundwater. The item highlights infants and young children as the most vulnerable population to lead exposure and underscores rice-consuming populations, particularly in parts of Asia irrigating paddy fields with arsenic-rich groundwater, as at risk for arsenic exposure. These contexts directly intersect with Codex limits for lead and arsenic, since supply-chain sourcing, irrigation practices, and processing choices determine achievable compliance.

Most important findings

Critical pointDetails
New ML for lead in infant formulaCodex adopted a maximum level of 0.01 mg/kg lead in infant formula as consumed, reflecting heightened neurodevelopmental vulnerability in infants and the feasibility of prevention via raw-material sourcing controls. For HTMC, this sets a measurable certification threshold for product release testing and supplier qualification.
First Codex ML for arsenic in riceCodex set 0.2 mg/kg as the maximum level for arsenic in rice, recognizing rice’s high uptake of arsenic and its central role in dietary exposure for millions. For HTMC, this enables a clear pass–fail criterion for rice and rice-derived ingredients used across infant foods and broader categories.
Exposure and health rationaleCodex agreed to develop a code of practice to help countries and producers meet the arsenic ML, providing practical guidance for prevention and reduction. Certification programs can align audit checklists with this code to ensure harmonized controls from the field to finished product.
Source and mitigation leversLead in formula can be minimized by sourcing inputs from low-lead regions; arsenic in rice can be reduced via improved irrigation (e.g., raised beds rather than flooded fields) and agronomic practices. HTMC protocols should embed farm-level verification of water sources, agronomic practices, and ingredient provenance mapping.
Implementation supportThe Commission recommended restricting eight veterinary drugs in food-producing animals and advanced controls on pesticide residues, food additives, fumonisins in maize, and new commodity standards—a context that signals broader contaminant governance relevant to multi-analyte HTMC panels.
Adjacent regulatory actionsThe Commission recommended restricting eight veterinary drugs in food-producing animals and advanced controls on pesticide residues, food additives, fumonisins in maize, and new commodity standards a context that signals broader contaminant governance relevant to multi-analyte HTMC panels.
Future Codex agendaForthcoming work includes MLs for cadmium in chocolate/cocoa, spice standards, and potential standards for ready-to-eat foods for malnourished children—areas that may expand HTMC’s scope beyond lead and arsenic.

Key implications

Codex limits for lead and arsenic will shape national rulemaking, import controls, and due diligence obligations. Certification requirements should codify validated methods for lead and inorganic arsenic, batch-wise ML conformity, supplier auditing, and farm-to-factory traceability. Industry applications include sourcing from low-contamination regions and arsenic-mitigating irrigation. Research gaps include region-specific uptake kinetics and process effects. Practical recommendations are to integrate Codex codes, set internal alert limits below MLs, and implement targeted surveillance of high-risk origins.

Citation

Codex Alimentarius Commission. Report of the 37th Session of the Codex Committee on Food Contaminants (CCCF); July 2014. Rome: FAO/WHO; 2014. (Noting adoption of ML 0.01 mg/kg lead in infant formula and 0.2 mg/kg arsenic in rice).

Lead (Pb)

Lead is a neurotoxic heavy metal with no safe exposure level. It contaminates food, consumer goods and drinking water, causing cognitive deficits, birth defects and cardiovascular disease. HMTC’s rigorous lead testing applies ALARA principles to protect infants and consumers and to prepare brands for tightening regulations.