Answer to a written question – Delays in EFSA risk assessments – E-000501/2025(ASW)

Source: European Parliament

The Commission acknowledges the European Food Safety Authority’s (EFSA) critical role in providing timely, robust, transparent and independent scientific advice concerning the EU food and feed sectors.

This is essential to ensure a high level of protection of human health and for evidence-based decision-making in the context of the operation of the internal market.

To address delays in risk assessments, EFSA has prioritised the speed and efficiency of its scientific advice production[1] in its multiannual programming plan.

From the experience gained, delays in assessing products requiring pre-market approval are mainly due to issues relating to the quality and/or insufficient data in application dossiers, leading to the need for (sometimes multiple) requests to applicants for providing additional information.

For example, during the yellow mealworm assessment[2] referred to by the Honourable Member, EFSA had to request three times additional information from the applicant, causing pauses in the scientific evaluation until the requested data was provided.

To address these challenges, EFSA has intensified efforts[3] to assist applicants, particularly small and medium enterprises (SMEs), in improving dossier quality, thereby reducing the overall time needed for risk assessments.

EFSA ensures transparency in relation to its risk assessments via the ‘Open EFSA’ platform, which enables all stakeholders to follow the process from the receipt of the dossier to the adoption of the relevant scientific output[4].

The Commission is currently evaluating EFSA’s performance[5], with the evaluation report due by March 2026, to identify potential improvements in the EFSA’s functioning and organisation.

  • [1] EFSA Programming Document 2025-2027 (page 10): https://www.efsa.europa.eu/sites/default/files/2025-01/programming-document-2025-2027.pdf
  • [2] Safety of frozen and dried forms of whole yellow mealworm (Tenebrio molitor larva) as a novel food pursuant to Regulation (EU) 2015/2283, adopted 28 November 2024, https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9155 (see at page 23, section ‘7. Steps taken by EFSA’).
  • [3] These efforts include for example: The updated EFSA’s Novel Food Scientific Guidance: https://www.efsa.europa.eu/en/efsajournal/pub/8961 (published in September 2024) providing advice for applicants on preparing novel food application dossiers; Call for expressions of interest targeting potential SME applicants who are interested in receiving EFSA’s pre-submission advice on the application requirements in novel foods: https://www.efsa.europa.eu/en/call/call-expressions-interest-efsas-advice-novel-food-smes-2025-edition; Call for expressions of interest in joining EFSA’s new stakeholder community on applications for food and feed products: https://www.efsa.europa.eu/en/call/call-expressions-interest-joining-efsas-new-stakeholder-community-applications-food-and-feed
  • [4] E.g. date of receipt and validation of the request, status of assessment, risk assessment deadline taking into account the ‘stop-the-clock’ periods in case of requests to applicants for additional information, publication date of the scientific output, etc. For more information, see at: https://open.efsa.europa.eu/
  • [5] Article 61(2) of Regulation (EC) No 178/2002. For more information, s ee at: https://food.ec.europa.eu/horizontal-topics/general-food-law/performance-evaluation-european-food-safety-authority_en?prefLang=da