EFSA Issues Positive Scientific Opinions on CLA Ingredients

The EFSA scientific opinion marks a major step to gaining novel food approval for two CLA products in Europe from Cognis and Lipid Nutrition.

25 May 2010 --- EFSA has delivered positive scientific opinions on two commercial CLA ingredients; Tonalin (Cognis) and Clarinol (Lipid Nutrition).

Global specialty chemicals supplier Cognis announced that the European Food Safety Authority (EFSA) concludes that the safety of Tonalin CLA has been established for defined uses as a food ingredient. The EFSA scientific opinion marks a major step to gaining novel food approval for Tonalin CLA in Europe.
 
Cognis was the first company in Europe to seek novel food approval for CLA, and the EFSA safety opinion is a necessary step towards obtaining it. 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. Tonalin CLA has already been granted FDA GRAS status in the US for multiple food applications. It is also the only CLA to achieve novel food approval in China, making it the only product of its kind authorized for use in food products for the rapidly growing Chinese market. In addition, Cognis has recently enhanced Tonalin CLA’s taste and sensory properties by incorporating an additional purification step during manufacturing. 
 
“We have been eagerly awaiting this opinion from the EFSA,” says Dr. Arne Ptock, Global Product Line Manager for Tonalin. “It represents a significant milestone for Cognis and for our customers towards gaining novel food approval for Tonalin CLA. We are confident that we will soon be able to take this final step and we are prepared to support the European market with extensive food application expertise. Our Tonalin CLA is already used in functional food products in different regions and recognized by consumers as a premium brand.”
 
“The issues of weight management and body fat reduction are ever-present in the minds of consumers,” comments Andreas Bais, Marketing Manager Nutrition & Health, Europe. “The demand for Tonalin CLA will continue to grow as consumers become more aware of the limitations of ‘quick solutions’ and of the need for a well-balanced and sustainable approach to body composition.”

The European Food Safety Authority (EFSA) has finalized its assessment of Lipid Nutrition’s Clarinol CLA in the EU’s Novel Food registration process. The Panel concludes that the safety of Clarinol CLA has been established. The positive opinion of the EFSA is a significant step forward in allowing Clarinol CLA to be used in food products throughout Europe.

The Novel Food approval is necessary to build a truly long-term, sustainable market for the ingredient’s use in foodstuffs. Once this has been acquired, it will open a new world of possibilities. The core conclusion of the EFSA Panel is that the safety of Clarinol has been established for the proposed intake necessary to attain the results as described by the weight management health claims, which are still under evaluation by EFSA as part of the article list of generic health claims.

This positive evaluation by EFSA of the safety of Clarinol is an important step in the novel food approval procedure. There is an overwhelming amount of published scientific information available about CLA, which has made this evaluation not an easy one for EFSA’s NDA Panel.

Katinka Abbenbroek CEO at Lipid Nutrition: “We are excited. This evaluation of the EFSA is an important milestone. This positive opinion will now be reviewed by the member states who will finalize the Novel Food registration process. Together with the recent GRAS approval for Clarinol CLA Lipid Nutrition will be able to help food companies capitalize on scientific substantiated research around weight management that largely is appreciated by their target consumer.”

Meanwhile following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to carry out the additional assessment for Clarinol, conjugated linoleic acid (CLA)-rich oil as a food ingredient in the context of Regulation (EC) No. 258/97 taking account of the comments/objections of a scientific nature raised by the Member States.

Clarinol is manufactured from safflower oil which is used directly or may be subjected to an enzymatic pre-processing to increase the linoleic acid content. Saponification and isomerisation (conjugation) are achieved by subsequent alkaline treatment under reaction conditions resulting in the formation of the c9,t11 and t10,c12-isomers in a ratio of 1:1. Following this isomerisation step, the mixture is diluted and acidified followed by washing, drying and distillation steps. The resulting free fatty acids are re-esterified with glycerol. The single steps of the process are procedures commonly applied in the isolation, refinement and modification of vegetable fats and oils.

Clarinol is intended by the applicant for use as an ingredient in beverages, cereal products, dietary supplements, milk products and dry weight beverages. The intended target consumers are adults. The applicant suggests a daily intake of 3 g CLA, corresponding to approximately 3.75 g Clarinol.