ERNA, in conjunction with other European food and food supplement trade bodies, submitted more than 700 claims to the European Commission, and ERNA secretary general, Patrick Coppens noted at least 80 of these claims were missing from the list.
Coppens said no reason had been provided by the Commission or EFSA, but suggested it was most likely because of EFSA's screening criteria which may have classed claims as too general, vague, medicinal, etc, without legal backing.
Flawed process
“Once again the flaws and lack of transparency in this process have been highlighted by the publication of this list,” Coppens told NutraIngredients.com this morning. “Where are the missing claims? Why have some been re-worded? We are seeking legal clarity on this and are hoping we will be able to work with the Commission and EFSA to provide it.”
He noted some claims have been eliminated because no “conditions of use” had been provided, but said in cases such as calcium, where a strong nutrient/health benefit relationship exists, the body of evidence is strong and use widespread, this kind of data was unnecessary.
The updated article 13 list of the EU health and nutrition regulation saw the list increase from about 2700 claims. Article 13 claims are more generic while article 14 claims are concerned with children’s and disease reduction.
Coppens said given the ‘gold standard’ scientific approach EFSA has taken to article 14 claims – which the assessor has stated will apply to all claims – the approval rate for article 13 claims was likely to be extremely low.
“We have little doubt that EFSA is going to reject 99 per cent of these claims,” he warned. “As it stands it is likely EFSA is going to say no to many well-backed claims because of their own peculiar criteria. EFSA needs to factor social responsibility into its processes but it doesn’t look like that is going to happen.”
As many article 13 claims relate to food substances that contribute to particular kinds of wellness but often not in a measurable way, the gold standard approach was not appropriate, he said.
“Many of the nutrients and substances that we eat have a certain function, and their intake is intended to contribute to the maintenance of that function, not necessarily to a measurable improvement of it,” Coppens said in an ERNA statement. “If EFSA does not appreciate this in its opinions, the list will be decimated.”
Timeframes
Coppens also questioned whether EFSA could issue more than 4000 opinions, have those opinions pass to the European Commission and 27-member states for further assessment, and then have final claims issued or rejected – all before a January, 2010 deadline – a mere 12 months away.
In the ERNA statement chairman, Gert Krabichler, said his group was pleased a final list had been published after a year of waiting but said the omissions and modifications needed to be addressed quickly.
“In a way it is inevitable that given the number of claims in the list, inconsistencies and errors creep in”, Mr Krabichler continued, “but we hope there will be an opportunity to clarify and rectify.”
EFSA’s agenda
EFSA has set out a timeline for assessing the article 13 claims as follows:
• End July 2009: Assess about 1000 main entries which have passed pre-screening and have not been substantially modified.
• End November 2009: Assess about 470 main claims that have been amended since their original submission in November 2008 but subsequently passed pre-screening.
• Deadline to be determined: Assess the remaining 2700 claims.