As all parties would probably admit in these stressful times for the European Union functional food industry, we are still some way away from resolving the core issues that resulted in the adoption of Regulation 1924/2006 – the 2006 nutrition and health claims regulation.
A lot of people are talking about ‘a third way’ and maybe that’s what we need. The European Food Safety Authority (EFSA) is keen to emphasise that good science is the only way as far as they are concerned but the regulatory process and EFSA’s resources have been stretched to breaking point. At the same time the discussion on whether they should charge fees to conduct assessments rumbles on.
In this environment the debate about EFSA’s scientific criteria and the quality of nutrition science has reached fever pitch. EFSA has been criticised heavily by sections of industry and academia over its scientific assessment criteria and the way its health claims assessment panel has reached its decisions. As its criteria has been criticised, so has its expertise on occasion.
But what makes an expert? Even the regulation states that in Article 12(c) “claims which make reference to recommendations of individual doctors or health professionals” shall not be allowed. Should this issue be focused on more specifically say by allowing EFSA to focus on the quality of scientific advice for health claims rather than evaluate all health claims?
How would it work? Firstly we can take several things from the current system.
- Guidelines for dossiers
- An EFSA process for evaluating the qualifications of experts that sit on panels
- A large number of eminent scientific experts that would like to work with EFSA with eminent qualifications but the time-commitment is too great and the financial benefit too small
- A large number of very frustrated applicants and potential applicants that cannot see the transparency of the process
- A European Union seeking to control budgets
Expert registration process
I propose the following:
- Claims evaluation experts must apply to EFSA for approval and registration of their skills and experience. If successful they go onto a register based specifically on areas of expertise.
- EFSA establishes parameters for panel numbers, codes of conduct and fee regulation if required.
- The company would then assemble
- the dossier in accordance with EFSA guidance
- the scientific review panel made of EFSA registered experts, in accordance with EFSA guidance on panels
- Issue a scientific report of the findings
- Notify the Commission of the claim if successful for the register. The scientific opinion would be publically available.
- To ensure that the procedure is accountable EFSA peer-reviews a specific number of health claim opinions each year. In cases of dispute it could act as arbiter.
- Most importantly, EFSA would have the power to remove experts from panels.
Ultimately what I am proposing is a mechanism in which the scientific experts are given a powerful tool for self-regulation, and in the end what a true scientist fears more than anything else is shame from his peers.
OK so most of you will be saying “hey that’s just like GRAS and the EU will never buy that”…Well it is but it isn’t because OK the advantages of GRAS are kept in this proposal. But the FDA does not regulate the experts on GRAS panels does it…?
In the end, imagine me as a salesman to all parties. I am offering:
– To keep the scientific procedures
– To allow EFSA to manage its resources properly
– To allow fair remuneration for experts
– To allow the applicant to control the timelines
– To provide transparency and the ability to provide additional information as requested by the experts
– To give the Commission and member states the power of audit
– To give EFSA the chance of peer-review
Is this kind of expertise achievable for the EU’s health claims system?
Nigel Baldwin is the Director of Scientific & Regulatory Consulting for Europe at Cantox Health Sciences International (firstname.lastname@example.org).