EC cans EFSA fees plan over income, independence concerns
After years of deliberation the EC working group said the introduction of a fee-paying structure could not be applied evenly to all food business operators especially smaller operators and that it would be difficult to ensure consultation fee-payers received the benefit of the work they paid for.
Generic article 13.1 health claims under the 2006 EU nutrition and health claims regulation (NHCR) are an example of this.
“An in-depth analysis of the options, in the light of the criteria and limits set forth in the IA [impact assessment], showed that none of those proposing the introduction of fees would ensure EFSA a satisfactory income, nor would they result in significant savings for the EU budget,” the EC working group said in its impact assessment.
“In addition, the fluctuating number of applications would give rise to some problems of manageability of EFSA's budget, creating a risk… that some resources for public interest tasks would be re-allocated to the assessment of regulated products.”
No gain
Jacqueline Mailly,senior EU regulatory affairs advisor at Brussels-based legal firm Hogan Lovells International welcomed the EC verdict.
“In the end it was too hard and there was no real gain so they abandoned it completely,” Mailly said. “Just as well though as in my view EFSA is really there to service public authorities.”
The working group considered four distinct options:
- Option 1: No policy change;
- Option 2: Application fee for all applicants for risk assessment of new and renewal applications (a sub-option 2, excluding sectors where initial assessment is performed by member states, was also analysed);
- Option 3: Application fee only for applicants who are authorisation holders for risk assessment of new and renewal applications (a sub-option 3, excluding sectors where initial assessment is performed by member states, was also analysed);
- Option 4: Fees for additional services for all applicants and for new and renewal applications.
In rejecting all options, it concluded, “that the funding system in place should be maintained since within the current context none of the options proposing the introduction of fees would bring a clear benefit either for EFSA or the EU institutions, or for stakeholders.”
