Speaking at a stakeholder meeting held at the European Food Safety Authority's (EFSA's) Parma HQ earlier this week, NDA panel chief Juliane Kleiner said the quality of the literature provided by applicants in the form of references to support claims had been "far from optimal".
Article 13.1 claims are based on 'generally accepted science' and were submitted for assessment by EFSA along with lists of references to supporting science.
However, the NDA panel, which is responsible for assessing the mountain of health claims applications submitted under the Regulation, said that along with the expected references to clinical studies published in peer-reviewed academic journals, it had also been presented with references from Wikipedia, press releases, dictionaries, the Bible and even an RAF report.
Trying to make sense of translations of references from other languages into English had presented additional difficulties, while 'clarifications' provided by some applicants in response to requests for further information had been confusing or inadequate, further delaying the process, claimed Kleiner, who gave a presentation on the claims process to stakeholders at the meeting.
1,080 opinions delivered; 3,557 to go...
However, considerable progress had been made to date, she stressed, with 1,080 opinions delivered on article 13.1 health claims (out of 4,637 received), and almost 100 opinions delivered on article 13.5 and article 14 claims.
The next batch of opinions on article 13.1 claims would be published in September, with all remaining opinions to be published by December 2011, she said.
However, this timetable might have to be "reconsidered in case new priorities emerge, in particular in the context of a possible resubmission under article 13.5 (claims based on new and emerging science) of those article 13.1 claims for which the panel already issued an opinion and which are on the European Commission's grey list", she revealed.
Insufficient guidance for industry
While some applications were clearly sub-standard, however, insufficient guidance at the beginning of the process as to what information was required for article 13.1 claims had also scuppered many applications, claimed Mella Frewen, director general of food trade association the CIAA.
In a presentation outlining the experience and expectations of the food industry in regard to the claims process, Frewen said food companies had only become aware of the detailed requirements for submissions under article 13.1 of the Regulation after the lists had been compiled.
And while EFSA was to be congratulated for "reviewing so many health claims in such a short time", the industry also had legitimate concerns about the lack of transparency in the claims process, the failure to conduct a proper impact assessment, the lack of legal certainty over timelines, the controversial decision to publish claims in batches, and the general complexity of the process, said Frewen.
More constructive dialogue between EFSA and applicants could have prevented both parties from wasting time and money on producing and processing dossiers that did not make the grade, she added.
"After three years, we believe that improvements to the implementation process can certainly be made."
Jaap Kluifhooft, regulatory director at Dutch healthy fats firm Lipid Nutrition, who attended the Parma meeting, told FoodManufacture.co.uk that many firms had been frustrated by the way that the article 13.1 claims process had been handled, because the lists were compiled and collated by Member States before guidance was issued as to what was required.
As the article 13.1 lists were generic, and did not refer to specific companies supplying the ingredients in question, it was also hard for EFSA to know who to contact if it needed further information while conducting assessments, he said. "The article 13.5 and article 14 dossiers are much easier for EFSA to process because all the information is in one place and there is a clear point of contact."