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 evaluates EU Regulation 2023/915 as consolidated on 1 July 2025, focusing on EU Regulation 2023/915 heavy metals and its direct relevance to Heavy Metal Tested and Certified (HTMC) program controls across food categories. The act establishes binding maximum levels for contaminants in food placed on the EU market, replacing Regulation (EC) No 1881/2006, and frames how limits apply to dried, diluted, processed, and compound foods with special provisions for infant and young-child products and for foods subject to sorting or physical treatment before retail placement.
Who was reviewed?
The regulation applies to food business operators supplying foods to the EU market, including primary producers, processors, importers, and retailers. It covers edible parts of foods at the point of marketing and specifies conditions for products intended for further sorting or physical treatment, while prohibiting deliberate chemical detoxification. Infant formulae, young-child formulae, baby foods, and drinks for infants receive dedicated, stricter limits, with transitional and staged-entry provisions for certain contaminant groups.
Most important findings
| Critical point | Details |
|---|---|
| Scope and legal force | Regulation (EU) 2023/915 is in force, sets maximum levels for contaminants in food, and is directly applicable across Member States. Consolidated version current to 01/07/2025; authentic text published in OJ L 119 (5 May 2023). |
| Application to processed, dried, diluted, and compound foods | Representative maxima include 0.10 mg/kg for meats, 0.30 mg/kg for muscle meat of fish and cephalopods, 0.50 mg/kg for crustacean muscle, 1.50 mg/kg for bivalve mollusks, 0.020 mg/kg for raw and heat-treated milk, and category-specific limits for spices and cereals. |
| Lead (section 3.1) – general foods | Representative maxima include 0.10 mg/kg for meats, 0.30 mg/kg for muscle meat of fish and cephalopods, 0.50 mg/kg for crustacean muscle, 1.50 mg/kg for bivalve mollusks, 0.020 mg/kg for raw and heat-treated milk, and category-specific limits for spices and cereals. |
| Lead – infant & young-child categories | Infant formulae and young-child formulae: 0.020 mg/kg (powder) and 0.010 mg/kg (liquid); baby food and processed cereal-based food: 0.020 mg/kg; drinks for infants and young children: 0.020 mg/kg in ready-to-use products. |
| Cadmium (section 3.2) | Cadmium limits span fruits, tree nuts (0.20 mg/kg; pine nuts 0.30 mg/kg), roots and tubers, cereals, and fishery products, with processing notes invoking Article 3 for dried/diluted/processed foods. |
| Mercury (section 3.3) | Mercury maxima include 0.30 mg/kg for certain fish and cephalopods, 0.10 mg/kg for food supplements and salt, with product-specific applications (e.g., cephalopods without viscera). |
| Inorganic arsenic (section 3.4) | Explicit inorganic arsenic limits for rice and rice-based products: non-parboiled milled rice 0.15 mg/kg; parboiled/husked rice 0.25 mg/kg; rice flour 0.25 mg/kg; rice cakes/waffles/crackers/flakes/popped breakfast rice 0.30 mg/kg. |
| Transitional and staged entries | Key dates include 3 May 2022 for mercury (3.3), 26 March 2023 for arsenic (3.4), 1 July 2025 and 1 July 2026 for newly introduced nickel limits (3.6) with staged application to certain sub-categories. |
| Derogations and special cases | Limited national derogations exist for Baltic region fish (dioxins/PCBs) and for traditionally smoked meats regarding PAHs, subject to consumer information and non-circulation to other Member States. |
Key implications
EU Regulation 2023/915 on heavy metals creates binding ceilings requiring validated analytical controls at product release and robust sampling aligned to edible parts. Certification requirements for HTMC include category-specific heavy metal panels, infant-focused stricter thresholds, and processing-factor adjustments. Industry applications span reformulation, sourcing controls, and supplier testing. Research gaps include matrix-specific bioaccessibility and processing effects. Practical recommendations prioritize risk-based testing plans, rice-origin management, fish species screening for mercury, and tight documentation of transitional dates.
Citation
Commission Regulation (EU) 2023/915 of 25 April 2023 on “Maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006“. Consolidated text current as of 1 July 2025. Official Journal of the European Union, L 119, 5 May 2023, p. 103.
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.
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.
