Company's plant sterol the only one of eight stamped for approval in first round of submissions
For many months the EU food community waited to see how the EFSA panel on Dietetic Products, Nutrition and Allergies (NDA) would react to the first set of health claims submitted under a newly devised system. With only one approval among the eight, the benchmark was set for tough standards, though the industry says questions remain about how to maneuver successfully through the regulatory labyrinth.
Among the eight, only Unilever's plant sterol was approved for its cholesterol-lowering potential and reduction in the risk of coronary heart disease. The approved health claim states: "Plant sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease." Though the committee noted that the product should only be used by those "who need and want to lower their blood cholesterol, and that patients on cholesterol-lowering medication should only consume the product under medical supervision."
The NDA Panel examined eight such claims in its first lot of submissions — five related to children's health under Article 13, and three under Article 14, generic disease-risk reduction.
Two common threads among the rejected claims were a lack of cause-and-effect relationship between the product and claim, and not enough scientific evidence to support the proposed claim. Though in other cases, such as Bio Serae's cactus fibre, the ingredient wasn't outright rejected, and the committee called for more information and clarification. The company plans to pursue this in hopes of reversing the decision.
Two petitions from Ireland's National Dairy Council on the role of dairy consumption and weight management and dental health failed because they used population studies as the primary science rather than clinical studies. It is this lack of available clinical trials that leaves many companies in a bind. Legal experts noted that the evidence EFSA requires is not often available, particularly for clinical studies related to children.