EFSA last week issued positive safety opinions on CLA ingredients from both Cognis and Lipid Nutrition, the two largest competitors that market Tonalin and Clarinol respectively.
In the opinions, published on Friday and adopted on April 30, EFSA concluded that both ingredients were safe at proposed doses for up to six months. However, safety was not established for periods longer than six months, or for consumption by people with type-2 diabetes.
Cognis said the EFSA opinion was “a necessary step” towards obtaining novel food approval for its CLA ingredient. In the next and final step of the approval process, the European Commission will present a draft decision to the Standing Committee on the Food Chain and Animal Health, which will make a final decision on the application.
Once this has been achieved, the ingredient will become available for use in foods and beverages in Europe. This follows the launch of certain CLA-containing food items in the United States, where Cognis and Lipid Nutrition both received GRAS (generally recognized as safe) status for their ingredients in 2008.
Fat reduction benefits
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.
Tonalin and Clarinol
EFSA’s Panel of Dietetic Products, Nutrition and Allergies reviewed data submitted by Cognis and Lipid Nutrition, which included animal studies on absorption, distribution, metabolism and excretion, as well as data on the toxicity of CLA.
“The available data from non-human studies do not indicate a risk for genotoxicity, reproductive toxicity, carcinogenicity or allergenicity,” wrote EFSA in both opinions.
It added that: “The Panel considers that CLA consumption does not appear to have adverse effects on insulin sensitivity, blood glucose control or liver function for up to six months, and that observed effects on blood lipids are unlikely to have an impact on cardiovascular risk. Long-term effects of CLA intake on insulin sensitivity and the arterial wall have not been adequately addressed in humans. The evidence provided does not establish the safety of CLA consumption by type-2 diabetic subjects under the proposed conditions of use.”
Cognis’ Tonalin ingredient was reviewed for its intended use in “milk-, yoghurt-, or fruit-type products and other unspecified products” at a daily intake of 4.5g Tonalin (corresponding to 3.5g CLA).
Lipid Nutrition’s Clarinol was reviewed for use in beverages, cereal products, dietary supplements, milk products and dry weight beverages, at a daily intake of 3.75g Clarinol (3g CLA).
Both ingredients are intended for use by adults.
EFSA’s opinion on Tonalin can be viewed here. The opinion on Clarinol can be viewed here.