The European Food Safety Authority (EFSA) has published the results of the first pilot phase of the EU monitoring program established for food additives, finding no safety concern with the levels of exposure to five substances.

The monitoring program was launched in response to a mandate from the European Commission to gather data on the consumption and use of food additives and to assess potential health concerns, helping to verify the dietary intakes estimated at the time of the additives’ authorizations or reevaluation, and support future risk management measures and risk assessments. The first pilot phase, which was executed during 2024, was organized to establish the necessary systems for data collection and reporting and inform refinements to future monitoring efforts.

Substances assessed in the pilot program were prioritized by the European Commission and EU Member States, and included three food additives, green S (E 142), ponceau 4R (E 124), and tartrazine (E 102); and two flavorings, caffeine and pulegone.

Data Collection and Analysis

For the pilot program, 22 Member States and five food business operators (FBOs) submitted 18,296 analytical results from 8,943 food samples and 663 use levels for the prioritized food additives and flavorings. Consumption data were retrieved from the EFSA Comprehensive European Food Consumption Database covering 46 dietary surveys from 23 Member States. Dietary exposures were assessed using three refined exposure scenarios: non-brand-loyal, brand-loyal, and “food supplement-consumer only” scenarios. The data and the exposure estimations were compared with those used in the most recent EFSA risk assessments for the five substances.

No Dietary Exposure Concerns Found

For the three food additives, all exposure estimates were well below their respective acceptable daily intakes (ADIs). For the flavoring pulegone, exposure estimates were below the tolerable daily intake (TDI).

For caffeine, exposure estimates did not exceed doses that presented any safety concern; particularly in adults and the elderly, whose exposures were largely driven by the consumption of foods with naturally occurring caffeine (e.g., coffee and tea) rather than foods with added caffeine. Although caffeine exposure was higher than in previous assessments, the current estimates are thought to be overestimated due to limitations in the concentration data and the methodology.

Pilot Program Takeaways for Future Monitoring 

Overall, various challenges and misreporting were identified that might have biased the dietary exposure estimations for the substances assessed. Therefore, conclusions derived in the framework of the first pilot are not yet considered to be sufficiently robust for decision-making, and further actions will be taken to strengthen the collection and analysis of the monitoring data for the next report.

Recommended corrective actions for future monitoring cycles include new validation rules, encouragement of more detailed coding for the FoodEx2 classification system, and the implementation of the Legal Limit Database to support compliance checks by data providers.

The second pilot monitoring program—which will evaluate the same five additives—is underway.