A crunch meeting with the European Food Safety Authority to discuss the fraught health claims approval process has left food and drink companies feeling short-changed.
About 120 delegates from businesses and consultancies packed into a conference room in Brussels on 15 June for the event, each of them eager to obtain guidance on how to negotiate the extraordinarily high scientific hurdles which must be overcome before EFSA's NDA panel will approve a claim.
But they were to be disappointed. In spite of EFSA's own assertion in a press release that the meeting was a success (see Functional Ingredients online for full story), those in the audience felt somewhat differently.
"Despite the EFSA PR, the event generally did not meet the expectations of the participants," said David Richardson of London-based consultancy DPR Nutrition, who was among the delegates. "Many answers to questions were unclear. Overall I wouldn't say we learned a lot and there was a huge degree of disappointment among those at the meeting."
Another attendee, Nino Binns of Ireland-based NB Consulting, concurred: "The mood was one of slight frustration. A lot of people said there wasn't anything new."
Addressing delegates were members of the NDA panel, including its chair Albert Flynn, and representatives from the European Commission. EFSA pledged at the meeting that it would be more transparent about how it reached its decisions on claims, and also promised to engage more effectively in dialogue with applicants.
But what was also clear from the get-together was that EFSA has no intention of reducing the high level of evidence it requires for claims to be approved, or the way in which it assesses that evidence.
"EFSA stood very firm in terms of the scientific hurdles," said Binns. "They didn't show any signs at all they were going to back down from that. They are willing to be more transparent about how they evaluate and weigh the totality of the data. But they say the Commission regulation that says how the EFSA approval process works states how they have to do it. That regulation \[353/2008\] can be amended and it wouldn't have to go back to Parliament because it's a Commission regulation, and I think there might well be a lobby from the industry to change it at one point. But for the moment EFSA are standing firm."
What many would like to see are visible signs that EFSA really is reaching its conclusions by "by taking into account the totality of the available scientific data and by weighing the evidence", which is what Regulation 353/2008 demands. From analysing opinions issued so far, there is a general feeling that EFSA is simply dismissing those studies it feels aren't up to scratch and basing its decision on those it considers suitable, such as randomised controlled trials. Some experts believe 'weighing the evidence' should instead involve grading different kinds of evidence so that certain types of studies are given greater influence than others, but all are taken into account.
EFSA refuted this criticism at the meeting, insisting it did always look at all studies submitted with a dossier. But Richards said: "They said they were weighing evidence. But they also said they had rejected the grading of the evidence into classifications such as convincing, probable, possible and insufficient, because the law does not require them to do this. So how they weigh the evidence remains to be seen. That was unclear." It may become clearer, of course, since EFSA's pledge to be more transparent about how it reaches its decisions will presumably become evident in the opinions it issues in future.
On a positive note, however, there was recognition that EFSA and the NDA panel were doing their best to make the approval process more open and to engage in dialogue with the industry. There was also a sense that the industry could do better in terms of presenting itself to EFSA. "One thing they said was that you should argue your case," said Binns. "Don't just present the data. Say why you think some studies are more important than others, and why you are coming to the conclusion that you are. And why you might disregard certain studies that are negative."
Generally, though, it seems the industry has little more to cling on to than it did the day before the meeting. "As far as I could see, the general message the industry got was 'business as usual'," said Richardson. "The meeting can't have done any harm; but it certainly gave us the feeling EFSA is just going to carry on as before."