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. 
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
The codex-lead-maximum-levels provisions in the Codex General Standard for Contaminants and Toxins in Food and Feed (Codex Stan/CXS 193-1995) set commodity-specific Maximum Levels (MLs) for total lead (Pb) across a wide range of foods and feeds, alongside interpretive notes on which portion of each commodity the ML applies to and where exemptions exist. This regulatory framework is explicitly linked to risk assessment work by JECFA and to Codex Codes of Practice intended to prevent and reduce lead contamination. A key scientific pivot embedded in the text is JECFA’s re-evaluation at its 73rd meeting (2010), concluding that the formerly used PTWI of 25 µg/kg body weight/week was not health-protective and therefore was withdrawn because population-level shifts in child IQ and adult blood pressure could occur even when individual effects appear small.
Who was reviewed
Rather than a single study population, the codex-lead-maximum-levels approach effectively “reviews” the global food supply chain as it reaches consumers, using commodity categories that represent both common dietary staples and sensitive-use products. The commodities covered span plant foods (fruits, berries, leafy vegetables, cereal grains, pulses, root and tuber vegetables), animal-derived foods (milk, meat, poultry, edible offal), aquatic foods (fish), processed foods (canned fruits/vegetables, preserved tomatoes, jams/jellies/marmalades, mango chutney, table olives), fats and oils, beverages (wine, fruit juices), and high-vulnerability items such as infant formula and natural mineral waters. In practical HMTC terms, “who” is represented by the consumers most affected by lead’s dose–response sensitivity, especially infants and children, and by the industry actors controlling exposure through agricultural sourcing, processing, packaging, and water inputs.
Most important findings
The codex-lead-maximum-levels matrix translates toxicological concern into enforceable MLs that differ sharply by product type, with especially low limits for infant formula, drinking waters, and juices, and higher allowances where lead is more difficult to avoid or concentrates through processing. It also specifies the exact edible portion to test and flags exemptions, which matters for sampling plans and certification pass/fail logic.
| Critical point | Details |
|---|---|
| PTWI withdrawn as not health-protective | JECFA (73rd meeting, 2010) concluded the prior PTWI of 25 µg/kg bw/week corresponded to ~3 IQ-point decreases in children and ~3 mm Hg systolic BP increases in adults at a population level, so it was withdrawn; HMTC should avoid treating “below PTWI” as a safety guarantee. |
| Highest-protection commodities have ultra-low MLs | Infant formula ML is 0.01 mg/kg (as consumed); natural mineral waters ML is 0.01 mg/L; these categories demand the tightest supplier qualification and most frequent lot verification. |
| Juices and milk have low MLs with category nuance | Fruit juices ML is 0.03 mg/kg (ready-to-drink), but 0.05 mg/kg for juices exclusively from berries/small fruits; grape juice ML is 0.04 mg/kg; milk ML is 0.02 mg/kg with concentration factor considerations for dried products. |
| Broad produce and staple categories have mid-range MLs | Many fruits and vegetables sit at 0.1 mg/kg (berries/small fruits often 0.1, with cranberry/currant/elderberry at 0.2); cereal grains and pulses are 0.2 mg/kg; fish is 0.3 mg/kg; leafy vegetables are 0.3 mg/kg, reflecting higher background or surface deposition risk. |
| Certain processed/specialty foods allow higher MLs | Jams/jellies/marmalades and mango chutney are 0.4 mg/kg; table olives are 0.4 mg/kg; edible offal of cattle/pig/poultry is 0.5 mg/kg; food-grade salt is 1 mg/kg—all of which signal where HMTC may require tighter internal “action limits” than Codex MLs to maintain a strong certification claim. |
| Portion definitions drive compliant sampling | ML applicability is portion-specific (e.g., peeled potato; fish generally after removing digestive tract; “as consumed” for canned goods and juices), meaning HMTC test plans must mirror Codex commodity preparation to avoid false compliance or false failure. |
Key implications
For codex-lead-maximum-levels, the primary regulatory impact is a commodity-by-commodity compliance map that HMTC can align to while setting stricter internal action levels for certification credibility. Certification requirements should specify matrix-matched testing (edible portion, “as consumed” basis), low-LOD methods, and elevated scrutiny for infant formula, waters, milk, and juices. Industry applications include supplier contracts with lead specs, soil/water risk screening, process controls to prevent concentration, and packaging contact evaluation. Research gaps include clearer links between commodity MLs and cumulative exposure across diets, plus better evidence on mitigation effectiveness by ingredient origin. Practical recommendations include risk-based lot testing frequency, tighter guardrails for high-risk ingredients, and corrective-action triggers below Codex MLs.
Citation
Codex Alimentarius Commission. General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995): Lead (total). Rome: FAO/WHO; 1995. (JECFA toxicological note references the 73rd meeting, 2010; specific update year for the Lead entry not provided in the supplied text.)
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.
