Speaking at a recent seminar at Vitafoods in Geneva, Mathioudakis, the EC’s head of Food Law, Nutrition and Labelling, publicly admitted for the first time that the volume of work was too great for the ambitious 2010 deadline to be met.
He said the fact many article 13.1 generic health claim dossiers had been sent back to the EC from the European Food Safety Authority (EFSA) for clarification had been an unexpected “complication”.
“Regarding the article 13.1 list this has caused considerable concern and nervousness among industry at this stage,” Mathioudakis said.
“Initially we had agreed with EFSA that opinions would be delivered in staged fashion in accordance with when they had been submitted.We are looking now for the best way to go forward to take into account these legitimate concerns. What I believe is we are going to be late to adopt the article 13.1 list.”
Mathioudakis admitted the staggered publishing of opinions had the potential to favour companies and disadvantage others.
“Despite what some say that we don’t listen, we are listening to that argument,” he said.
Any delay was welcomed by Peter Van Doorn, chairman of the European Federation of Associations of Health Products Manufacturers (EHPM), who called for the brakes to be put on the process and a period of reflection entered into.
“The general feeling is this is all going very fast,” he said at the seminar. “We need some time to sit down and look at what is happening. There needs to be a time-out.”
Van Doorn also questioned the selection of the opinions published so far, noting that as many of them related to "weak dossiers", they had the potential to sway public opinion against industry.
EFSA’s stated intention to apply “gold standard” clinical trial criteria across-the-board in assessing health claims was questioned by Van Doorn, who said different standards were required and that a reassessment of claim verification criteria was required.
But Mathioudakis countered by saying that he did not agreethat "health claims were different”.
“It should be remembered that this was a decision taken by the Parliament to require dossiers on claims made on products for children (article 14) but it is not written anywhere that it should be different [for different types of claims].”
He said what mattered was that EFSA carried out a “correct evaluation on quality, quantity and nature of the evidence”.
“If there is a supplementary role for the risk manager to give any leeway, I don’t think it is that EFSA should apply different criteria for different claims.”
“But the debate about the effect on research possibilities and innovation that a very strict application of the criteria is going to have is going to go on.”
Mathioudakis said he had not seen any preliminary drafts of article 13.1 opinions, 1000-or-so of which are due for publication in July.