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
This review covers eu-food-heavy-metal-limits as established in Commission Regulation (EU) 2023/915, a consolidated EU legal framework that sets enforceable maximum levels for contaminants in foods and replaces Regulation (EC) No 1881/2006. The Regulation establishes general compliance rules (no placing on the market above limits; no mixing to dilute noncompliance), and it operationalizes how limits apply to foods “as placed on the market,” edible portions, and to dried/diluted/processed/compound foods via justified processing or concentration factors supplied by food business operators.
Who was reviewed
Rather than enrolling human participants, the Regulation applies to the regulated population of foods and actors in the EU food chain: food business operators placing products on the market, competent authorities performing official controls, and downstream consumers—explicitly recognizing infants and young children as a vulnerable group for whom stricter, achievable maximum levels and raw-material selection are emphasized. For a heavy metal certification program, the “who” is therefore the set of food categories listed in Annex I (e.g., cereals, spices, oils, fishery products, infant foods) and the operators responsible for demonstrating compliance and traceability across those categories.
Most important findings
For eu-food-heavy-metal-limits, the most actionable content is Annex I’s metal maximum levels and the Regulation’s control logic: limits apply to the edible part as marketed, prohibit dilution by mixing, and require defensible processing/concentration factors for composite products—directly shaping how an HMTC certification should define sampling, product form, and pass/fail thresholds.
| Critical point | Details |
|---|---|
| “Do not place on the market” and “do not mix” rules | Foods exceeding Annex I maximum levels cannot be marketed or used as ingredients, and compliant foods cannot be mixed with noncompliant lots—closing a common loophole where blending might otherwise hide elevated metals. |
| How to handle processed/compound products | When a product is dried, diluted, processed, or multi-ingredient without a specific maximum level, operators must provide justified concentration/dilution/processing factors and ingredient proportions with supporting data; authorities can override factors to maximize health protection if justification is missing or weak. |
| Lead limits are commodity-specific and portion-defined | Lead maximum levels vary by category (e.g., many fruits at 0.10 mg/kg, cereals at 0.20 mg/kg, muscle meat of fish at 0.30 mg/kg), with repeated instructions that limits apply after washing/separating edible parts and, for fish, sometimes to whole fish when eaten whole—important for HMTC sampling plans and label claims. |
| Cadmium limits include notable high-risk matrices | Cadmium maximum levels differ sharply by commodity, including higher allowances in some matrices (e.g., cocoa/chocolate tiers up to 0.80 mg/kg depending on cocoa solids; certain oilseeds like poppy seeds up to 1.20 mg/kg), and special rules for cereals used for brewing/distilling when residues are not marketed as food—critical for ingredient screening and finished-product certification. |
| Mercury and inorganic arsenic are tightly scoped | Mercury limits are primarily defined for fishery products with species-based maxima (commonly 0.50 mg/kg, up to 1.0 mg/kg for specified species), while inorganic arsenic maxima focus on rice and infant-related foods (e.g., non-parboiled milled rice 0.15 mg/kg, rice destined for infants/young children 0.10 mg/kg, baby food 0.020 mg/kg), aligning HMTC priorities with known exposure drivers. |
Key implications
For eu-food-heavy-metal-limits, the primary regulatory impacts for HMTC are that certification thresholds should map to Annex I maxima, prohibit “pass-by-blending,” and define compliance on the edible portion and marketed form. Certification requirements should include validated sampling plans, matrix-specific limits (especially fish, rice/infant foods, cocoa, spices), and documented processing/concentration factors for powders, extracts, and composites. Industry applications include supplier qualification and batch release testing tied to risk matrices. Research gaps include harmonized conversion factors for complex products and improved occurrence data for certain categories. Practical recommendations include setting HMTC action limits at or below Annex I, requiring factor justifications, and flagging infant/young-child products for stricter screening.
Citation
European Commission. Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006. Official Journal of the European Union. 2023;L119:103–157.
Heavy metals are high-density elements that accumulate in the body and environment, disrupting biological processes. Lead, cadmium, arsenic, mercury, nickel, tin, aluminum, and chromium are of greatest concern due to persistence, bioaccumulation, and health risks, making them central to the HMTC program’s safety standards.
