Clarinol closer to Novel Foods approval

The FSAI handed down a positive opinion on Lipid Nutrition's "thick file" which has now been passed to the European Commission for assessment by the EU's 27 member states and finally, the European Food Safety Authority.

The approval is a significant step in Dutch-based Lipid Nutrition's attempt to gain EU Novel Foods approval for Clarinol, its proprietary version of CLA, which is most commonly used as a weight management aid.

Clarinol has been on the European market for more than a decade but only in food supplement form and not long enough to be exempt from long-winded Novel Foods approval under the 1997 rule.

That rule states any products on-market in one or more EU member states before May 1997 do not require Novel Foods approval.

Over to you, member states The FSAI approval brings Clarinol a step closer to EU-wide approval in foods but Jaap Kluifhooft, director of regulatory affairs at Lipid Nutrition, said it was unknown how long that might take given the standard assessment timeframes of the Novel Foods process.

"The summer will be critical," he told NutraIngredients.com.

"If progress is made this summer than there is every chance the Novel Foods decision could be made by year's end.

But we have to be realistic and accept that it might take longer than that."

The EU is considering streamlining the Novel Foods process by removing the mandatory condition that every member state be granted the opportunity to comment on each application, as well as other time-saving measures, but these changes were unlikely to be in time to speed Lipid Nutrition's application.

The company had also applied for GRAS (generally regarded as safe) status with the Food and Drug Administration (FDA) and expected a verdict on that application by year's end.

Lipid Nutrition submitted its application with the FSAI in October 2007 and praised the agency for working quickly.

"We submitted to FSAI because the Dutch, UK and Belgian agencies were snowed under and we thought the FSAI would be able to do a quicker job which has turned out to be the case," Kluifhooft said.

Sixty per cent of Novel Food applications are first assessed by the food agencies in the Netherlands, the UK and Belgium.

He added: "We trust that the other member states working alongside the European Commission will support and endorse the Irish positive opinion.

This is sometimes a complex procedure, however we are confident that European approval will follow in the near future for Clarinol CLA" .

Potential food applications for the ingredient derived from natural safflower oil include dairy products, beverages such as shakes and bars.