EU Commission bins conclusions of the Ombudsman

DG SANTE misleadingly accepted Ombudsman’s solutions

In 2013 the Pesticide Action Network lodged a complaint with the EU Ombudsman on the derogation used by Commission service DG SANTE called „confirmatory information” This derogation makes it possible to approve pesticides even when the EU Food Authority EFSA has not concluded they are safe to use and when important data gaps still exist. These derogations have allowed for bans and discontinuation of use of numerous pesticides to be avoided, and has gradually become a standard procedure used by DG SANTE.
In 2016, the Ombudsman published their „solutions” for this type of  derogation, and DG SANTE largely agreed with them . SANTE was obliged to publish a report in response to the Ombudsman’s findings within two years, showing that they had indeed changed their practices.
It now turns out that, according to DG SANTE’s own report from 2018, they didn’t implement any changes at all, reneging on their agreement with the Ombudsman and going back on their word. Here are the conclusions of the Pesticide Action Network on the SANTE report, send in a letter to DG SANTE:

SANTE didn’t implement any of the solutions of the Ombudsman:

  • there is no significant decrease in the number of approved substances using the confirmatory information derogation as requested by the Ombudsman; 
  • the confirmatory information procedure is not used restrictively and is not used in line with the Regulation (Art. 6.f, Reg. 1107); 
  • SANTE did not consider whether confirmatory data produced should be systematically subject to an EFSA peer review; 
  • SANTE did not review their approach to the definition of mitigation measures;
  • SANTE did not review whether its approval decisions included further requirements according to EFSA conclusions;
  • SANTE rejected the proposal of the Ombudsman to systematically verify mitigation measures at national level;
  • SANTE kept on producing ‘Review reports’ and approval decisions that were classified by the Ombudsman as “misleading and inaccurate”. 

The Pesticide Action Network notes that the Ombudsman placed too much trust in SANTE’s statements, and instead of trying to reach an agreement with DG SANTE on the “solutions”, should have simply condemned DG SANTE for illegal action and maladministration. 

1.,   see report Ombudsman, February 2016, page 22.


© PAN Europe, Rue de la Pacification 67, 1000, Brussels, Belgium, Tel. +32 2 318 62 55

PAN Europe gratefully acknowledges the financial support from the European Union, European Commission, DG Environment, Life+ programme. Sole responsibility for this publication lies with the authors and the funders are not responsible for any use that may be made of the information contained herein.