Despite the European Food Safety Authority (EFSA) last year issuing positive Novel Food safety opinions for Lipid Nutrition’s Clarinol ingredient and Cognis’s Tonalin, Food Standards Australia and New Zealand (FSANZ) holds to a view that CLA is a TFA that can affect HDL and LDL cholesterol levels and thereby increase coronary heart disease (CHD) risk.
The FSANZ position provoked Lipid Nutrition to withdraw it Novel Foods application in the two countries to see how the situation develops, especially in regard to the EU Novel Foods applications that are due to be debated at a European Commission Standing Committee on the Food Chain and Animal Health (SCoFCAH) meeting today.
“We want to wait for the approval of CLA as a food ingredient in the EU and then progress further with submissions in other regions of the world, such as Australia and New Zealand,” said Lipid Nutrition’s director of regulatory affairs Jaap D Kluifhooft.
Kluifhooft observed that while EFSA and FSANZ safety assessments had found CLA could cause small changes in HDL and LDL cholesterol levels, the EFSA assessment differed because the agency concluded the changes were unlikely to impact CHD. FSANZ, on the other hand, said the change was, “non-trivial” and could contribute to an increase in cardiovascular disease risk.
Ruminating on TFAs
The FSANZ takes a broad definition of TFAs. Its website states: “Trans fatty acids means the total number of unsaturated fatty acids where one or more of the double bonds are in the trans configuration and declared as trans fat.”
Kluifhooft said this was problematic because it grouped all TFAs together when the healthful properties of individual TFAs were vastly different, and said the classification differed from that of many other countries including many EU member states.
“This difference is based on the fact that there is a clear and proven difference between functional, structural and metabolic aspects of the fatty acids beyond their actual chemical structure,” he said. “But the FSANZ approach closely follows the chemical definition of trans configuration in fatty acids, and includes all types of TFA.”
CLA is a fatty acid naturally present in ruminant meat and dairy products. It has been linked to the reduction of body fat and the increase of lean muscle but its health claim proposals were rejected by EFSA last year prompting both Lipid Nutrition and Cognis to commit to resubmissions under a different section of the nutrition and health claims regulation (NHCR).
The EU Novel Foods application seeks approval to use the ingredient in milk beverages; fermented milk beverages; soy beverages and yoghurt products (all at 1g/100g maximum).
It has GRAS (generally recognized as safe) status in the US and so has been able to be used in certain foodstuffs there since 2008.
EFSA’s opinion on Tonalin can be viewed here . The opinion on Clarinol can be viewed here .