The depressingly high rejection rate for ‘article 13.1’ health claims is hardly surprising given the nature of the submission process, according to one member of the expert panel tasked with assessing them.
Seppo Salminen - a member of the NDA panel at the European Food Safety Authority (EFSA) - was speaking to FoodManufacture.co.uk after a tense exchange about the claims assessment process during a Q&A session at the International Functional Foods conference in Oxford last Friday.
While some applications were simply sub-standard, said Salminen, insufficient guidance from the European Commission at the beginning of the process as to what information was required for article 13.1 claims had also scuppered many applications.
The 40,000+applications for article 13.1 claims, which are based on ‘generally accepted science’, were collated and filtered by the Member States to avoid duplication and then submitted to EFSA as a list of 4,637 claims coupled with academic references.
Article 13.1 submissions: 'Difficult to come to a constructive end result'
Unlike article 13.5 and 14 applications, which are submitted by individual applicants via dossiers that collate, weigh, analyse and contextualise the supporting evidence submitted, the 13.1 list is generic. This meant EFSA had no clear point of contact to approach with follow-up questions and no certainty that the evidence presented was reflective of the science in the field in question, said Salminen.
“I really don’t see a great future for the 4,600+ claims. The Commission never gave the Member States enough guidance and advice on how the claims should be substantiated, so we have incomplete dossiers if you can call them dossiers and it’s been very difficult to come to a constructive end result.
“It was also done at very short notice. But it’s not the fault of the companies or the Member States.”
Totality of the data?
One of the key problems was that it was impossible to know whether the data supplied to EFSA in the 13.1 submissions reflected the totality of the scientific evidence supporting the claims in question without a huge amount of investigative work on EFSA’s part, which was not in its remit, he said.
“Sometimes there were discrepancies between what data is available [to support a claim] and what was actually submitted to us for assessment.”
But EFSA could only work with what it was given, he said: “It is the applicants’ task to guide us and not expect us to guess what is out there. Looking at the data for the 4,600+ article 13.1 claims, I don’t think that many people would come to different conclusions than the [NDA] panel.”
Multiple re-submissions were now envisaged as firms frustrated by the article 13.1 process applied via articles 14 or 13.5, which enabled them to exercise far greater control over the process, he predicted.
“Maybe the [article 13.1] claims might not be approved in their current format but they might be approved under a new process."
However, it was also important to stress that many applications were woefully inadequate, while references provided to support them were in many cases far from ‘academic’ (excerpts from the Old Testament, Wikipedia, a Tea Association press release, a Royal Air Force report and the American Heritage Dictionary to name a few).
Other submissions just didn’t warrant serious scrutiny, he said, citing a particularly weak application: “I would ask you would you approve this ingredient if you were presented with that kind of evidence?”
Weighing the data
However, frustrations from the floor of the conference hall went far beyond the inadequacy of the article 13.1 submission process, and several delegates at the event (hosted by the functional food centre at Oxford Brookes University) said EFSA’s approach to assessing scientific evidence was not consistent with the wording of the legislation.
Professor David Richardson, a former chief scientist at Nestlé UK and now an independent consultant, said: “The health claims Regulation states that we should look at the totality of the available data. It also says that you have to weigh the evidence, and look at the extent to which a causal relationship between a food and a health benefit has been demonstrated, rather than seeking absolute proof.”
Danisco’s scientific and regulatory affairs expert Dr Julian Stowell also took issue with a claim made by McNeil Nutritionals’ Colette Shortt that the claims Regulation would stimulate innovation, adding: “I would just like to ask on what basis you believe this Regulation will encourage innovation?”
Shortt said she stood by her view, but accepted the process had been “difficult”.
But it did at least mean the harmonisation of rules across the EU, she said. “At least a roadmap is now there and once you have got a claim you can market it in 27 Member States. In the past you had to go country by country so this really simplifies the process.
"That’s my perspective, although you might not agree with it.”
What happens next?
EFSA’s opinions are sent to the European Commission and Member States, which ultimately decide whether to approve them or not.
Successful 13.1 claims will be added to an EU-wide register of approved claims available for all food manufacturers to use provided they meet the conditions of use. Evaluations of all 13.1 claims (excluding botanicals) have been promised by June 2011, with the publication of an approved list likely to follow in 2012.