Seeking approval

Jaap Kluifhooft, Director, Regulatory Affairs at Lipid Nutrition gives us an insight into the Current Regulatory Position of Clarinol CLA.

“Clarinol CLA is safe for use as an ingredient at levels up to approximately three to six grams per day”
-Jaap Kluifhooft

Governmental bodies are, understandably, extremely cautious about allowing the inclusion of any kind of new ingredients in items meant for human consumption. The approval process is always a long one, even for products, which are 100 percent vegetable in origin, such as Clarinol CLA.

Conjugated linoleic acid (CLA) is the term given to a group of positional and geometric isomers of octadecadienoic acid. The conjugated double bonds (i.e. the 2 double bonds are separated by 1 single bond) can be present in either the cis or trans configuration and are present predominantly in positions 9 and 11 or 10 and 12. CLA-rich oil like Clarinol is a food-grade preparation derived from processed safflower oil and contains a 50:50 mixture of these two isomers.

Clarinol CLA reduces body fat mass and increases lean body mass contributing to improved shape in specific regions of the body and thus enhancing weight control. The effective dose of CLA is 1.7 g - 3.4g/active isomers CLA per day.

In May 2007 a panel of qualified experts concluded, based on a critical evaluation of the scientific information, that Clarinol CLA is GRAS, when meeting appropriate food grade specifications and produced by consistent and current good manufacturing practice.

Clarinol CLA is safe for use as an ingredient in certain specified foods within the general categories of soy milk beverages, meal replacement beverages, meal replacement bars, flavoured milk products, filled milk, yogurt products, and fruit juice products at a level not to exceed 1.5 g CLA per serving, with expected use of approximately two servings per day. The conclusion from the Expert Panel that Clarinol CLA is GRAS, was approved by the FDA in July 2008.

Clarinol CLA has been commercially available on the food ingredients (supplement) market since 1996, with no adverse health effects reported. Therefore it can be concluded that CLA is on the EU-market as a safe and suitable ingredient for more than a decade and before the entry into force of the EU Novel Food Regulation 258/97 on 15 May 1997.

The publication of the General Food Law (178/2002) and the Food Supplements Directive (2002/46) in 2002 resulted in extensive discussions between EU Member States on the legal implications of the Food Supplements directive in relation with the Novel Food Regulation. This political discussion ended with an opinion of the EU Standing Committee on 14 February 2005 that the use of foods and/or food ingredients in the EU exclusively as, or in, food supplements would not be considered to be "a significant human consumption" within the meaning of the Novel Food Regulation.

To clarify this uncertain regulatory situation in Europe for CLA, a novel food -registration would be necessary. For that reason a novel food file was submitted in 2007 in Ireland. In May 2008 the Irish FSAI delivered a positive opinion on Clarinol CLA. The Irish opinion has been sent to the European Commission and the other EU Member States and is currently being discussed in EFSA. A final conclusion by the European Commission and Member States will probably be reached in early 2010. This will enable existing and new product developments in the USA and in Europe in this commercially very interesting area.

Jaap Kluifhooft is Director, Regulatory Affairs at Lipid Nutrition. He is a professional in Regulatory Affairs and has a broad knowledge of international food legislation and the politics behind these rules.