April 05, 2025

The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) play crucial roles in the regulation and assessment of chemicals, particularly pesticides and biocides, within the European Union. Their collaboration ensures that chemical safety assessments are harmonized, transparent, and scientifically robust, contributing to a high level of public and environmental health protection.

EFSA and ECHA: A Coordinated Approach

The collaboration between EFSA and ECHA is formalized through a memorandum of understanding, facilitating information exchange and coordinated evaluations. Their joint efforts include:

  • Work plan exchanges to align assessments.
  • Mutual data access to improve evaluation efficiency.
  • Observer participation in each other’s meetings.
  • Scientific divergence resolution, where disagreements are assessed jointly and, if necessary, a joint statement is issued.

One key area of collaboration is the harmonized classification and labelling (CLH) of pesticide active substances. Ideally, both agencies work in parallel using the same data, with EFSA incorporating ECHA’s classifications into its assessments. However, ECHA is the sole authority responsible for adopting harmonized classifications under the CLP Regulation (EC No 1272/2008). If a Member State has not submitted a classification proposal to ECHA, EFSA may develop an ad hoc classification based on ECHA guidelines, but it does not carry the legal status of a harmonized classification.

For example, in the case of glyphosate, ECHA’s classification of the substance as not carcinogenic influenced EFSA’s risk assessment, which ultimately concluded that glyphosate was unlikely to pose a carcinogenic risk to humans. Such cases demonstrate the interplay between the two agencies in regulatory decision-making.

Engagement with International Organizations

Beyond intra-EU collaboration, EFSA engages with international regulatory bodies such as the OECD, WHO, FAO, and IARC. These partnerships focus on methodological developments, risk assessments, and hazard evaluations.

While no formal divergence-resolution mechanisms exist for non-EU assessments, EFSA reviews third-party conclusions and may reassess substances if significant discrepancies arise. A notable example is the 2014 reassessment of chlorpyrifos, triggered by international findings on human health risks.

Independence, Consultation, and Transparency

EFSA upholds stringent independence standards aligned with the EU Staff Regulations, ensuring impartiality in its assessments. Transparency is another cornerstone of EFSA’s operations, demonstrated by:

  • Annual declarations of interest by staff.
  • Involvement of national experts and scientists in peer reviews.
  • Public consultations to incorporate diverse viewpoints.

Additionally, EFSA’s website provides full traceability of scientific decisions, making all relevant documents publicly accessible, including:

  • Summaries of applicant-submitted dossiers.
  • Draft and final assessment reports with modifications highlighted.
  • Peer review reports capturing expert comments and public inputs.
  • Final EFSA conclusions on active substance safety.

Furthermore, EFSA assesses pesticide residues in food under Regulation (EC) No 396/2005, ensuring compliance with Maximum Residue Levels (MRLs) and evaluating consumer dietary exposure to support risk-based decision-making.

Maven’s Role in Pesticide and Biocide Risk Assessment

Maven plays a pivotal role in supporting regulatory compliance and toxicology risk assessments for pesticides and biocides, ensuring that products meet EU and international safety standards. Maven provides expert services that bridge scientific evaluation with regulatory requirements, including:

  • Comprehensive Toxicological Risk Assessments: Conducting hazard identification and dose-response evaluations to assess human and environmental safety in line with EFSA and ECHA guidelines.
  • Regulatory Dossier Preparation: Assisting companies in compiling high-quality classification and labelling dossiers for active substances, including physicochemical, toxicological, and ecotoxicological data.
  • Harmonized CLH Submissions: Supporting industries in preparing scientific justifications and addressing data gaps to align with regulatory expectations.
  • Exposure and Risk Characterization: Performing occupational, consumer, and environmental exposure assessments to evaluate potential risks associated with pesticide and biocide use.
  • Endocrine Disruptor and Residue Analysis: Ensuring compliance with EFSA’s endocrine disruptor guidance and conducting residue analysis to meet Maximum Residue Levels (MRLs) regulations.
  • Scientific Advocacy and Consultation: Engaging with regulatory bodies and scientific committees to ensure accurate representation of safety data and facilitate decision-making.
  • Post-Market Surveillance and Safety Monitoring: Providing ongoing risk management strategies, including post-market evaluations, monitoring of adverse effects, and updates to safety assessments based on emerging data.

With deep regulatory expertise, Maven assists industries in navigating complex compliance requirements, ensuring product safety and market approval.

Conclusion

The synergy between EFSA and ECHA exemplifies the EU’s commitment to rigorous chemical safety assessments. Their structured collaboration, combined with international engagement and a transparent review process, ensures that regulatory decisions are scientifically sound and publicly accountable.

As chemical regulations continue to evolve, Maven’s expertise in toxicology and regulatory services plays a critical role in helping industries meet compliance standards. By providing scientific, regulatory, and risk assessment support, Maven contributes to the advancement of evidence-based policy-making and global chemical safety standards.