Both the European Commission and the European Food Safety Authority (EFSA) have published guidance and there have been many examples to follow. But is everything working as it should be?
‘Almost’ in my opinion, but there remain a number of issues that have not been addressed.
Take the situation of omega-3 form EPA (eicosapentaenoic acid) and ADHD (attention deficit) symptoms. EFSA’s NDA health claims panel has said, “that the claimed effect relates to the treatment of a disease, and that therefore the health claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.”
Out of scope?
Surprisingly enough this is more or less the same conclusion as for at least 10 opinions including six full submissions.
Now this may have been a bit understandable back in 2008 but Commission Regulation 1924/2006 (the nutrition and health claims regulation (NHCR)) and its implementing measures clearly put the initial responsibility on the member state to check whether the application is within scope, with the Commission to assist.
Then the submission goes to EFSA where it is checked again before being accepted. So why is EFSA reviewing an application that is out of scope?
Why are they then issuing an opinion that concludes with what appears to be a regulatory assessment? Is it EFSA’s responsibility to issue an opinion that an application does not comply? Is this risk management?
Given the recent EPA-ADHD opinion, there remains a need for a procedure where borderline cases can be reviewed from a regulatory perspective before wasting EFSA’s time. Or authorise EFSA to reject applications that they consider out of scope rather than to carry on scientifically in the hope that someone will resolve the issue.
Then there is this business of dossier withdrawal. Everyone agrees that it’s another waste of EFSA’s resources to take up valuable plenary time when an opinion looks like it’s going to be negative. Indeed it is written into the regulations that applicants can withdraw up to the adoption of an opinion.
What is not specifically written is a procedure that says EFSA must do this. I.e. that if the working group recommend a negative conclusion, EFSA should be obligated to inform the applicant and offer them the chance to withdraw. I cannot see a downside of this.
Applicants will be grateful for the opportunity to rectify situations and EFSA’s plenary meetings would have far fewer items on the agenda. If you look at the last couple of years’ opinions and how many are negative you would have to say that maybe as much as a third of the agendas of NDA panel plenary meetings could be saved if the negative opinions from working groups were not reviewed and withdrawn beforehand.
A sustainable approach?
The demands on EFSA are ever-increasing from all directions, it clearly has more work than it can cope with, so why don’t we use some common sense, ‘tweak’ a couple of implementing regulations to save those precious resources and provide a more flexible and constructive and most importantly sustainable environment for applicants and experts alike?
Nigel Baldwin is director of Scientific and Regulatory Consulting in the European Office for Intertek.