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
EU Regulation 2023/915 heavy metal limits are defined in Commission Regulation (EU) 2023/915 (25 April 2023), which sets legally binding maximum levels for certain contaminants in foods placed on the EU market and repeals Regulation (EC) No 1881/2006. For an HMTC program, the core “metals and other elements” provisions operationalize compliance by linking food-category-specific thresholds (in Annex I) to enforceable market access rules: food exceeding an Annex I maximum level “shall not be placed on the market” and may not be used as a raw material or ingredient. The text also establishes how to treat dried, diluted, processed, and compound foods through concentration/processing factors, preventing simple formulation changes from bypassing maximum levels. It further prohibits deliberate detoxification by chemical treatments, reinforcing that certification must reflect prevention and control rather than post hoc “fixes.”
Who was reviewed
Rather than studying people, EU Regulation 2023/915 heavy metal limits apply to food business operators, importers, and manufacturers placing foods on the EU market, with special attention to vulnerable consumer groups via distinct limits for infant formulae, baby foods, and young-child products. In practical HMTC terms, the “who” includes producers of raw and minimally processed commodities (fruits, vegetables, cereals, milk, honey), processors of high-risk ingredients (cocoa/chocolate, seaweed-derived supplements, salts), and seafood supply chains where mercury and cadmium limits vary by species and edible portion. The regulation also anticipates enforcement realities by specifying where limits apply (edible part; as placed on the market; wet weight for many foods) and by requiring that operators bear the burden of proving lawful market placement dates when transitional measures are used.
Most important findings
For HMTC alignment, EU Regulation 2023/915 heavy metal limits convert toxicology risk management into auditable, category-specific thresholds, with especially stringent requirements for infant and young-child foods and clear rules on processing, edible parts, and marketability.
| Critical point | Details (HMTC-relevant specifics) |
|---|---|
| Market prohibition tied to Annex I thresholds | Foods listed in Annex I that exceed maximum levels cannot be placed on the market or used as raw materials/ingredients, making pass/fail decisions straightforward for certification. |
| Lead limits with infant-focused stringency | Lead is regulated across many commodities; examples include fruits at 0.10 mg/kg (with certain berries at 0.20 mg/kg), raw/heat-treated milk at 0.020 mg/kg, honey at 0.10 mg/kg, and salts at 1.0 mg/kg (unrefined “fleur de sel/grey salt” at 2.0 mg/kg). Infant formulae are set at 0.020 mg/kg (powder) and 0.010 mg/kg (liquid), and baby food/processed cereal-based infant foods at 0.020 mg/kg. |
| Cadmium limits vary by food type and concentration risk | Cadmium includes distinct thresholds for fish and cocoa/chocolate: muscle meat of many fish at 0.050 mg/kg, with higher allowances for specific fish groups (e.g., 0.10–0.25 mg/kg in listed categories). Cocoa/chocolate thresholds scale with cocoa solids (e.g., milk chocolate <30% cocoa at 0.10 mg/kg; chocolate ≥50% cocoa at 0.80 mg/kg). Infant-category cadmium limits include formulae at 0.020 mg/kg (powder) / 0.010 mg/kg (liquid) and baby/processed cereal-based infant foods at 0.040 mg/kg; seaweed-heavy supplements can be permitted up to 3.0 mg/kg. |
| Mercury and inorganic arsenic are explicitly structured for high-risk matrices | Mercury is set for fishery products with species-specific maxima (notably 1.0 mg/kg for certain listed fish; 0.30 mg/kg for other listed groups) and also covers supplements and salt at 0.10 mg/kg. Inorganic arsenic (sum As(III)+As(V)) targets rice and infant products: non-parboiled milled rice at 0.15 mg/kg; parboiled/husked rice and rice flour at 0.25 mg/kg; rice cakes/crackers/waffles at 0.30 mg/kg; rice destined for infant foods at 0.10 mg/kg; rice-based drinks at 0.030 mg/kg; and infant formulae/baby foods at 0.020 mg/kg (powder) / 0.010 mg/kg (liquid) and 0.020 mg/kg respectively. |
| Processing rules and anti-detoxification safeguard compliance integrity | For dried/diluted/processed/compound foods without specific maxima, operators must account for concentration/dilution and processing effects when applying Annex I limits, supporting HMTC conversion-factor documentation. Deliberate chemical detoxification of Annex I contaminants is prohibited, favoring source control and validated physical reduction steps over chemical “remediation.” |
Key implications
EU Regulation 2023/915 heavy metal limits drive primary regulatory impacts by making Annex I thresholds a market-access gate, so HMTC certification should require product-category mapping, validated sampling plans, and laboratory methods that match “as placed on the market” and edible-part rules. Certification requirements should emphasize infant and young-child foods as a highest-stringency tier, plus documented processing/concentration factors for powders, extracts, and multi-ingredient products. Industry applications include supplier qualification for rice, cocoa, seaweed supplements, and seafood species controls for mercury. Research gaps remain around harmonized conversion-factor conventions and how best to verify non-chemical reduction steps without creating new residues, so practical recommendations include HMTC-specific guidance on factor calculation, batch traceability, and risk-based re-testing triggers.
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.
