BASF and Stepan Lipid Nutrition lodge joint CLA health claim

04-Sep-2014 - Last updated on 08-Sep-2014 at 11:01 GMT

Body fat mass reduction claim submitted to EFSA. Photo credit: Helga Webber

BASF and Stepan Lipid Nutrition have submitted a joint EU health claim to say the firms’ conjugated linoleic acid brands contribute to body fat mass reduction.

Stepan’s CLA brand Clarinol and BASF’s version Tonalin are marketed as weight management products and can be added to supplements, bars and ready-to-drink shakes. The CLA-products are currently being evaluated for EU novel food approval.

The Article 13.5 health claim, presented to the European Food Safety Authority (EFSA), reads: “Consumption of Clarinol or Tonalin contributes to reduction in body fat mass.” The claim relates to 4 g of Tonalin or Clarinol per day, which provides 3 g of pure CLA in both cases.

CLA is intended to block an enzyme called lipoprotein lipase and divert unused fat to muscle cells. The ingredient also activates another enzyme, which is meant to help muscles burn the fat more easily.

EFSA no-no’s

In 2010, EFSA rejected a series of Article 13.1 health claims for CLA. These included ‘increase in lean body mass’, ‘protection of DNA, protein from oxidative damage’ and ‘contribution to the maintenance or achievement of a normal body weight’.

EFSA also precluded CLA claims for an ‘increase in insulin sensitivity’ and ‘contribution to immune defences by stimulation of production of protective antibodies in response to vaccination’.

Fresh research

Jaap Kluifhooft, head of regulatory and scientific affairs at Stepan Lipid Nutrition, and Bernd Haber, head of regulatory affairs at BASF Human Nutrition, said in a joint statement that the 2010 evaluation examined body weight reduction and did not evaluate the effect of body fat reduction itself.

“An evaluation of all actual available data highlighted the overall effect of Clarinol or Tonalin on body fat reduction. In addition, a meta-analysis was conducted, which confirmed a significant reduction from baseline in body fat measurement, relative to the consumption of a placebo.”

The BASF and Stepan pair said that numerous literature had become available after 2010 that supported the new health claim.

BASF and Stepan Lipid Nutrition have identified 14 randomized, double-blind, and placebo-controlled studies with Clarinol or Tonalin to give credence to the claim.