Struggle to meet deadline for health claims

The European Food Safety Authority (EFSA) will struggle to meet its deadline for assessing the health claims it is processing under article 13.1 of the EU Nutrition and Health Claims Regulation, according to food law consultancy EAS.

Stefanie Geiser, regulatory affairs manager at the firm’s Italian branch, said: “The volume of claims and currently proposed evaluation timelines illustrate that it will prove difficult for it to adopt the Community list of generic health claims by the official deadline.”

EFSA has committed to evaluating 1,024 of the 4,185 article 13.1 claims in its in-tray by July 31 and a second tranche of 468 claims by November.
This leaves 2,693 claims requiring assessment before the January 2010 deadline by which the European Commission is required to publish the Community list.
A delay could prove frustrating for firms waiting to see if claims they are using will gain approval. But it would mean that the transition period granted for companies to get their products in line with the Regulation would have to be extended, predicted Geiser.
Article 13.1 claims refer to the role of a nutrient/substance in growth, development and the functions of the body; psychological and behavioural functions; and weight control. They are based on “generally accepted science”. Claims that have been approved will become available for any company to use, provided they adhere to the conditions of use.
It is impossible to predict how many of the 4,185 article 13.1 claims will be approved. But applicants following the claims process under article 14 of the same Regulation will not be feeling optimistic given the large percentage that have been rejected to date.

Indeed, fears that the article 13 list could be decimated have been growing steadily in recent weeks, as several high-profile applications have been rejected.

The most recent is from Ocean Spray. It proposed that cranberry proanthocyanidins helped “reduce the risk of urinary tract infection in women by inhibiting the adhesion of certain bacteria in the urinary tract”. It was a claim many industry observers believed was one of the strongest in EFSA’s in-tray.
However, the application was rejected on the grounds that half of the 12 studies submitted as evidence were not relevant, while the others had “significant limitations”
Scores of other high profile applications have been rejected, including one from Unilever proposing that black tea could help focus attention and enhance alertness. A raft of others proposing a link between omega-3 fatty acids and learning, brain development and concentration in children have also been canned.