Consumers and Health

Nickel limits in foods: Regulation (EU) 2024/1987

July 18, 2025

1505

Commission Regulation (EU) 2024/1987 represents a landmark regulatory development in EU food safety, establishing for the first time maximum levels of nickel in sixteen food categories through an amendment to the food contaminants regulation (EU) 2023/915, with progressive implementation starting from 1 July 2025.

This regulation finally addresses the major public health concerns identified by the European Food Safety Authority (EFSA), particularly the need to protect both vulnerable consumers – notably infants and children up to 10 years of age – and individuals sensitive to nickel exposure, who account for approximately 15% of the population.

Table of Contents

Introduction and regulatory context

The establishment of maximum levels for nickel in foodstuffs represents a fundamental paradigm shift in EU food contaminant control policy. Prior to 2024, no maximum levels existed in EU legislation for nickel as a contaminant in foodstuffs, despite growing scientific evidence of potential health risks. Commission Regulation (EU) 2024/1987 fills this critical regulatory gap by establishing binding limits across 16 major food categories, covering everything from tree nuts to infant formula.

The regulation is built upon a robust scientific foundation derived from comprehensive risk assessments conducted by EFSA. The initial scientific foundation was established through EFSA’s 2015 assessment, which recognized nickel as a public health concern not only for allergic reactions and contact dermatitis, but also for reproductive and developmental toxicity, and established a tolerable daily intake (TDI) of 2.8 μg/kg body weight per day (EFSA CONTAM Panel, 2015). However, recognizing the need for more comprehensive data, the European Commission recommended enhanced monitoring of nickel in food from 2016 to 2018 through Commission Recommendation (EU) 2016/1111.

Building upon this expanded dataset, EFSA conducted an updated risk assessment in 2020, analyzing more than 47,000 analytical results from the enhanced monitoring program. This comprehensive review utilized revised benchmark dose guidance and newly available scientific information to establish an updated TDI of 13 μg/kg body weight per day, based on post-implantation loss in rats as the critical chronic effect (EFSA CONTAM Panel, 2020). The updated assessment identified significant health concerns, particularly noting that chronic exposure exceeded the TDI in toddlers in 10 out of 14 dietary surveys and in children aged 36 months to 10 years in 11 out of 19 dietary surveys.

Scientific foundation and health risk assessment

The scientific foundation underlying Commission Regulation (EU) 2024/1987 demonstrates the evolution of EFSA’s understanding of nickel-related health risks. The 2020 EFSA assessment established that nickel may cause both chronic and acute effects in humans:

For chronic exposure, the critical effect identified was increased incidence of post-implantation loss in rats, with a benchmark dose lower confidence limit for 10% extra risk (BMDL10) of 1.3 mg Ni/kg body weight per day serving as the reference point for establishing the TDI of 13 μg/kg body weight per day (EFSA CONTAM Panel, 2020).

The assessment revealed particular concerns for vulnerable populations. Even though pregnancy loss is not directly relevant to young age groups, the TDI also provides protection against other effects relevant to younger populations, such as neurotoxic effects. The Authority concluded that exceedance of the TDI may raise health concerns in young age groups, with particular attention to toddlers and children between 36 months and 10 years old, and in some cases, infants;

for acute exposure, EFSA identified eczematous flare-up reactions in the skin elicited in nickel-sensitized humans as the critical effect. This condition, known as systemic contact dermatitis, affects approximately 15% of the population. The assessment established that the lowest observed adverse effect level for these acute effects is 4.3 μg nickel/kg body weight, requiring a margin of exposure (MOE) of 30 or higher for protection. However, this protective MOE was not achieved for mean and 95th percentile exposure levels, raising health concerns for nickel-sensitized individuals.

Regulatory framework and legal integration

Regulation (EU) 2024/1987 amends Regulation (EU) 2023/915 on food contaminants by introducing:

a new entry (3.6) in Annex I, Section 3, dedicated to ‘Metals and other elements’;

an amendment to Article 10.1, aimed at including transitional provisions for nickel limits.

The regulation’s implementation mechanism ensures its direct applicability in all EU Member States, establishing binding obligations for food business operators and control authorities.

Specific maximum levels and food categories

The EU regulation establishes differentiated maximum levels of nickel in food, based on the natural accumulation patterns of nickel in various food categories and their relative contribution to total dietary exposure:

tree nuts are subject to a general limit of 3.5 mg/kg for most varieties. A higher threshold (10 mg/kg) is permitted for chestnuts, pine nuts, walnuts, Brazil nuts, and cashews, reflecting their naturally higher nickel content. Specific exemptions apply to nuts intended for crushing and oil refining, provided that crushing residues do not enter the food supply chain;

vegetables are regulated with differentiated thresholds based on their nickel uptake characteristics:
- root and tuber vegetables: 0.90 mg/kg (wet weight, after washing and preparation);
- fruit and stem vegetables: 0.40 mg/kg;
- brassica and leafy vegetables: 0.50 mg/kg;
- fresh herbs: 1.2 mg/kg;

legumes are generally limited to 1.0 mg/kg, with a notable exception for soybeans and edamame, which are allowed a higher limit of 6.0 mg/kg, due to their elevated natural nickel content;

cereals are subject to a general limit of 0.80 mg/kg, with higher limits specified for:
- durum wheat and rice: 1.5 mg/kg;
- brown (hulled) rice: 2.0 mg/kg;
- pseudocereals and millet: 3.0 mg/kg;
- oats: 5.0 mg/kg (dehulled), 7.5 mg/kg (with hulls);

foods intended for infants and young children (up to 3 years of age) are subject to the strictest nickel limits, including:
- liquid infant formula: 0.10 mg/kg;
- powdered formula: 0.25 mg/kg (up to 0.40 mg/kg for soy-based powder);
- baby foods: 0.50 mg/kg;
- processed cereal-based foods for infants and young children: 3.0 mg/kg.

Implementation timeline and transitional provisions

The gradual implementation of Regulation (EU) 2024/1987 ensures a balance between public health protection and the practical needs of the food supply chain. Specifically:

From 1 July 2025, the regulation applies to all food categories except cereals;

From 1 July 2026, the nickel limits are extended to cereals as well.

The transitional provisions allow products that were legally placed on the market before the respective implementation dates to remain available until the end of their shelf life, ensuring continuity for food business operators while upholding EU food safety standards.

Analytical compliance and monitoring framework

The implementation of nickel limits requires robust analytical capabilities and standardized monitoring procedures. Commission Implementing Regulation (EU) 2024/1045 amends Regulation (EC) No 333/2007 to establish specific methods for nickel sampling and analysis in foodstuffs. This implementing regulation ensures standardized sampling procedures across Member States, reliable and comparable analytical results, and quality assurance through certified reference materials.

The primary analytical technique employed is Inductively Coupled Plasma Mass Spectrometry (ICP-MS), which provides the sensitivity and precision necessary for accurate nickel quantification at the established limits. Alternative methods, including ICP-OES and AAS, are acceptable for specific matrices, with typical detection limits of 0.005 mg/kg for most food matrices. Sample preparation must conform to EN 13804:2013 standards, ensuring consistency in analytical procedures across laboratories.

Quality control requirements include regular participation in proficiency testing schemes, use of certified reference materials for method validation, implementation of harmonized reporting formats for regulatory compliance, and standardized uncertainty calculations. These measures ensure that analytical results are reliable, comparable, and legally defensible for regulatory enforcement purposes.

Systematic monitoring and data collection

Commission Recommendation (EU) 2024/907 establishes a comprehensive monitoring framework for the period 2025-2027, designed to gather additional occurrence data and support future regulatory refinements. This recommendation requires Member States, in cooperation with food business operators, to monitor nickel levels in specific food categories that may contribute significantly to dietary exposure but lack sufficient occurrence data for initial limit setting.

The monitoring scope encompasses food supplements, chocolate and chocolate spreads, nut spreads, cocoa beans, cereal products including breakfast cereals and cereal flakes, ready-to-eat soups, coffee and tea, vegetables and seaweed, oilseeds and soy products, pulses and nuts, and fish and seafood. Data collected through this monitoring program will be compiled into a centralized database managed by EFSA, using standardized electronic reporting formats to ensure consistency and comparability.

Beyond data collection, the monitoring recommendation encourages Member States to gather knowledge on mitigation measures for reducing nickel levels in food. This research component supports industry adaptation efforts and contributes to the development of best practices for nickel reduction throughout the food supply chain.

Clinical relevance and health protection

The regulation’s approach to limit setting reflects a sophisticated understanding of nickel toxicology and exposure patterns across different population groups. The differentiated limits recognize that nickel accumulation varies significantly across food types due to factors including soil conditions, plant physiology, and processing methods. Tree nuts and oilseeds naturally contain higher nickel levels due to soil uptake patterns, while cereals typically show moderate levels but contribute significantly to exposure through high consumption frequency.

The regulation provides particular protection for vulnerable populations, with infant and young children’s products receiving the strictest limits. These limits acknowledge that infants and young children have higher intake per body weight ratios, increased sensitivity to contaminants during developmental periods, and limited dietary diversity that can concentrate exposure risks.

For the approximately 15% of the population who are nickel-sensitive, the regulation’s limits are designed to reduce acute exposure risks that could trigger systemic contact dermatitis. While the regulation cannot eliminate all acute exposure risks, the maximum levels represent a significant reduction in exposure potential, particularly from frequently consumed foods that previously lacked regulatory oversight.

Supply chain implications and industry adaptation

The regulation’s implementation requires significant adaptations throughout food supply chains. Food business operators must develop comprehensive testing programs for raw materials, implement supplier qualification processes that ensure compliance with nickel limits, and establish systematic monitoring procedures.

The delayed implementation for cereals provides time for agricultural producers to evaluate and potentially modify cultivation practices, for processors to assess and upgrade equipment, and for traders to establish compliance verification systems.

Industry adaptation strategies include the development of risk-based approaches to identify high-risk ingredients and suppliers, implementation of systematic testing protocols with appropriate sampling frequencies, development of corrective action procedures for non-compliant products, and maintenance of comprehensive documentation systems for regulatory compliance. These adaptations represent significant investments but are essential for maintaining market access and consumer confidence.

International context and trade implications

The Nickel Regulation (EU) 2024/1987 could influence the evolution of international food safety standards, encouraging the adoption of equivalent legislation in other jurisdictions. Current World Health Organization guidelines set limits on nickel only in drinking water, without accounting for its presence in other food matrices.

The commercial implications of the regulation are nonetheless significant, as products intended for the EU market will be required to comply with the new nickel limits, regardless of their country of origin. This new regulatory landscape may shape the strategies of global suppliers, prompting the adoption of specific certification procedures to ensure market access for food commodities in the EU.

Future outlook and regulatory evolution

The implementation of Regulation (EU) 2024/1987 marks the beginning of a new phase in the management of nickel safety in food, rather than a final resolution. The comprehensive monitoring programme, established through Commission Recommendation (EU) 2024/907, will generate valuable new data on nickel occurrence in food, enabling more accurate risk assessments and potentially leading to revisions of maximum levels based on actual exposure patterns as well as the industry’s capacity to adapt.

Conclusion

The regulation under review introduces the first comprehensive framework for managing nickel in food within the EU, grounded in EFSA assessments and occurrence data, with particular focus on vulnerable groups and individuals who are sensitive or allergic to this metal.

The gradual implementation of limits and transitional measures allows food business operators to adapt their internal procedures to ensure compliance with the new rules.

Finally, the harmonised system of analysis and monitoring sets a precedent for improving the regulatory approach and controls concerning other food contaminants as well.

Dario Dongo

References

Commission Implementing Regulation (EU) 2024/1045 amending Regulation (EC) No 333/2007 as regards the methods of sampling and analysis for the control of levels of nickel in foodstuffs and amending certain references. http://data.europa.eu/eli/reg_impl/2024/1045/oj

Commission Recommendation (EU) 2016/1111 on the monitoring of nickel in food. http://data.europa.eu/eli/reco/2016/1111/oj

Commission Recommendation (EU) 2024/907 on the control of nickel in food. http://data.europa.eu/eli/reco/2024/907/oj

Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006. Consolidated text: 01/01/2025. http://data.europa.eu/eli/reg/2023/915/2025-01-01

Commission Regulation (EU) 2024/1987 amending Regulation (EU) 2023/915 as regards maximum levels of nickel in certain foodstuffs. http://data.europa.eu/eli/reg/2024/1987/oj

EFSA CONTAM Panel (European Food Safety Authority Panel on Contaminants in the Food Chain). (2015). Scientific opinion on the risks to public health related to the presence of nickel in food and drinking water. EFSA Journal, 13(2), 4002. https://doi.org/10.2903/j.efsa.2015.4002

EFSA CONTAM Panel (European Food Safety Authority Panel on Contaminants in the Food Chain). (2020). Scientific opinion on an update of the risk assessment of nickel in food and drinking water. EFSA Journal, 18(11), 6268. https://doi.org/10.2903/j.efsa.2020.6268

Regulation (EC) No 333/2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs. Consolidated text: 30/04/2024 http://data.europa.eu/eli/reg/2007/333/2024-04-30