The University of Lyon professor, who has stated that probiotic claims can win claims in 1-2 years, said the agency’s approach to nutrition science was becoming easier to understand by commercial and academic players as guidance in various areas has been circulated.
But communication with industry remains problematic.
“The contact with applicants is a delicate issue – it has to be solved to be solved by politicians and risk managers,” Martin said. “The problem now is that there are so many accusations about the contact between experts and the industry that we have to be very careful about private discussions.”
Resourcing
“I have no problems with general symposiums but to have a specific counsel for a specific dossier for a specific claim, it’s very difficult for us. I prefer pedagogic behavior. For the moment it is not possible but in the future pre-clinical discussions could be possible. Why not? It works in the drug area.”
“The problem is that there are not so many industry groups and enterprises in the drug area as in food. It would be very time and human resource consuming.”
Rejection ratios
Martin said the percentage of positive opinions stemming from his panel was indeed very low – around10% - but he warned this figure should be put into the context of the many hundreds or thousands of article 13.1 dossiers that are now known to have been poorly constructed.
“The success ratio is very low but it is biased by the first applicants who were coming with dossiers that were not very good. I hope that the quality of the dossiers will improve in the future.”
He said antioxidants, which had not fared very well so far, could win claims. “There is no controversy. From our guidance we accept that antioxidants can be beneficial but the effect should be demonstrated not just in vitro but by the fact that important molecules in the body are effectively protected. So it is very precise and we have been very precise on the markers we are accepting in DNA, lipid and protein damage.”
“Specific culture of interpretation”
Martin said interpretation of the regulation had evolved under his predecessor, professor Albert Flynn, and he did not disagree with it.
“It is true that a specific culture of interpretation has been built during the six previous years and we cannot change abruptly – and there is no reason to change abruptly. I was part of the building of this culture so we are in the same culture.”
“The nature of the studies and scientific substantiation can improve of course – this is the nature of science.”
Botanicals
For about 1500 botanical applications that are on hold as the European Commission and member states try to determine if tradition of use data should be acceptable or not, the professor suggested it should not.
“There is nothing in the regulation to have a specific approach for botanicals because tradition of use data is not mentioned. When we are assessing the effect of cherries for example – why should they be different to green tea extracts?”