With concern about the severity of EFSA’s health claim rulings raging at Health Ingredients Europe (HIE) trade show in Paris this week, Professor Albert Flynn, chair of the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA), told NutraIngredients.com that EFSA had no intention of changing its assessment criteria and methodologies.
Indeed, Professor Flynn said there was no room to manoeuvre in its approach to the nearly 3000 dossiers it has to pass opinion on by January, 2010, as the assessment agency was simply following guidelines written into the nutrition and health claims regulation that passed into European Union law in 2006.
No room for change
He said those that criticised EFSA for what is widely perceived as an inappropriate drug-like analytic method, were channelling their efforts at the wrong body, because EFSA’s course had been set by the regulation and could not be altered.
If industry was unhappy with EFSA’s methodology, then it should look to the regulation and the legislative arms of the EU, and not blame a scientific agency that was merely fulfilling its mandate as written in the regulation, he added.
Professor Flynn confirmed a major industry concern that generic article 13 claims will be assessed in the same manner as children’s and disease reduction article 14 claims.
“All article 13 and 14 claims will be assessed under the same criteria as was made clear in guidelines issued last year,” he said.
There is greater scope for flexibility in interpretation when the scientific assessments are handed to the European Commission and the 27 Member States, as EFSA’s opinions are not binding, and so industry waits with bated breath for the first mandating of EFSA’s opinions due in coming months.
If, for instance, EFSA deems there is insufficient evidence linking vitamin C and immunity due to a lack of human intervention trials, it may be that the Commission and the Member States will view such an opinion within the scope of a wider pool of nutritional data and approve some kind of claim.
Articles 13 and 14
EFSA would clear the 200 or so remaining article 14 claims by mid-2009, according to Professor Flynn, and was in the process of rationalising the 2500+ article 13 claims list as many dossiers were incomplete and did meet basic assessment criteria. But the regulator expected to receive a further batch of article 13 claims from the Commission next year that may total in the thousands.
Many large and small suppliers at HIE expressed concern about the direction Europe’s health claims system was heading, with the lack of noticeable ingredient innovation at the show being blamed in part on uncertainty created by the process.
The lack of proprietary protection written into the regulation was one particular bugbear.
“The fact the regulation offers only five years of proprietary protection on claims companies may spend millions of euros on is a tragic situation that is reducing research budgets and slowing innovation,” said Beneo Group executive board member, Yves Servotte.
So far EFSA has ruled on 22 claims, with positive opinions issued on five. Dossiers from the likes of Unilever, Bio Serae Laboratoires, Martek and Valio have been rejected.
To access EFSA’s opinions click here.
NutraIngredients.com will next week publish an exclusive podcast interview with Professor Flynn.