February 21 will see the EC’s Standing Committee on the Food Chain and Animal Health (SCoFCAH) entertain member state views on draft opinions for the use of proprietary versions of CLA owned by market leaders Lipid Nutrition and BASF-owned Cognis in foodstuffs across the EU.
CLA is available in dietary supplements in the EU but requires Novel Foods approval for use in the food supply, a process that began in 2007, when the first Novel Foods application was made for CLA.
The SCoFCAH will assess virtually identical EC draft opinions for Lipid Nutrition’s Clarinol ingredient and Cognis’s Tonalin. If there are no major objections, it is expected the opinions could be recommended for adoption into EU lawbooks at the following SCoFCAH meeting, slated for May, 2011.
The draft opinions propose permitting CLA for use in:
- Milk beverages
- Fermented milk beverages
- Soy beverages
- Yoghurt products (all at 1g/100g maximum)
But the opinions note the EFSA safety findings that called for further data to affirm the safety of Clarinol and Tonalin after six months consumption, and therefore call on Cognis and Lipid Nutrition to engage in a “post launch monitoring program” to assess usage levels until 2016.
The EC will feed some of this information to EFSA for ongoing review by 2015 at the latest.
Finger on the pulse
Lipid Nutrition’s director of regulatory affairs Jaap D Kluifhooft said it was difficult to predict what kind of queries might come in from the member state representatives, but the qualifier in the EFSA opinion may be a point of focus.
“The draft opinion states that we have to keep our finger on the pulse regarding use but the fact that EFSA called for more safety data may lead to a few questions from some member states,” Kluifhooft acknowledged.
“But it is up to the risk managers now to assess this.”
The draft opinion also notes that if foods are to contain CLA, labelling must indicate, “people with diabetes type-2 should only consume the foods containing conjugated linoleic acid under medical supervision”.
Both Cognis and Lipid Nutrition received GRAS (generally recognized as safe) status for their ingredients to be used in certain US foodstuffs in 2008.
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.
Due to changes in the Western diet, average intake of CLA from the diet has fallen; if the fat is removed from a dairy product to make a low fat version that will be acceptable to consumers, CLA is removed along with it.