EFSA – Copper: Harmonised approach for the dietary risk assessment

Copper is a multi-source substance: while it is an essential micronutrient for human life, it is also ubiquitous in the environment and widely used as a fungicide in agriculture. In light of this complexity, following the public consultation held between November 2025 and January 2026, EFSA published a new technical report on March 9, 2026, proposing a harmonised, stepwise approach for the assessment of the dietary risk associated with copper residues.

Traditionally, the consumer exposure risk assessment for pesticide residues uses PRIMO (Pesticide Residue Intake Model) and only considers intakes from the use of plant protection products (PPPs). However, due to the ubiquity of copper, EFSA recently conducted a comprehensive dietary exposure assessment. In this context, this report addresses the need to clarify how dietary risk assessment should now be conducted within the various regulatory frameworks applicable to PPPs. The report formalises a screening methodology for the preliminary risk assessment of copper compounds, while continuing to use the PRIMo 3.1 tool as the basis for calculations. Exposure assessment using this approach will only be necessary for new uses or representative uses requiring a modification of existing MRLs and not covered by the comprehensive assessment of EFSA.

The eight key steps of this approach consist of:

– Step 1: verify whether the uses not covered by the comprehensive assessment of EFSA, are on any of the 30 major commodities identified as significant contributors to the European diet,

– Step 2: if so, compare the mean residue concentration from the new trials (STMR) with the mean concentration data considered by EFSA,

– Steps 3 to 8: if the STMR from the new trials is higher, calculate the additional contribution using the PRIMo 3.1 tool, add it to the existing overall exposure from all sources, and compare the final total exposure to the Acceptable Daily Intake (ADI) to assess the risk.

A case study focusing on bulb vegetables, head cabbages, and dry beans illustrates the application of this approach in the document.

The comprehensive dietary exposure assessment is the one carried out by the EFSA Scientific Committee. The Commission intends to update this assessment every three years, based on the latest available occurrence data.

To download: 

Approach for the dietary risk assessment of copper compounds under different plant protection product (PPP) regulatory frameworks (EFSA, 2026)

Statement on the update of maximum residue levels (MRLs) for copper compounds in light of the EFSA scientific opinion on there-evaluation of the health-based guidance values (HBGVs) and exposure assessment from all sources (EFSA, 2025)

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