EFSA considered several new studies and reports from the Netherlands, Australia, Belgium and France but held to its earlier conclusion that CLA was safe to use, although, as in its 2010 opinion, the agency said evidence was lacking to show safety if CLA consumption extended beyond six months.
Stepan Lipid Nutrition head of regulatory and scientific affairs, Jaap D. Kluifhooft, said the sector was relieved that EFSA had held fast to its earlier position after assessing the new material.
“This is basically good news as they have been very consistent and understood the nuances of the Australian position where CLA was mixed with other fatty acids and its ability to raise blood lipid levels for instance,” Kluifhooft said.
“They have been clear in stating that the post-six month safety question cannot be answered by data available but they do not say it is unsafe. This we expected but the stale mate remains in that the opinion now passes back to the European Commission and member states where some of these new elements have influence.”
“Novel foods approval remains a challenge because of this.”
Stepan Lipid Nutrition and BASF-Cognis have for several years been attempting to win European Union novel foods approval for their Clarinol and Tonalin branded CLA forms but have to-date been frustrated despite recent approvals in the US and China.
The ingredients, typically marketed with body toning and weight management claims are however approved for use in food supplements in Europe, although EFSA controversially rejected a raft of proposed health claims in 2010.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA)states in its new opinion: “The Panel considers that the additional information provided does not contain evidence that would modify its previous conclusions regarding the effects of CLA on insulin sensitivity/glucose metabolism, blood lipids, lipid peroxidation, or subclinical inflammation.”
“The Panel concludes that the safety of Clarinol and Tonalin TG 80 has been established for the proposed uses and daily doses for up to six months. The safety of CLA consumption for periods longer than six months has not been established under the proposed conditions of use. The safety of CLA consumption by type-2 diabetic subjects has not been established.”
The NDA opinion can be found here.