Mary Gilsenan, Head of Regulatory Services at UK-based Leatherhead Food Research, supports the approach being taken by the European Food Safety Authority (EFSA) and thinks there is much that can be gleaned from the first series of article 13.1, 13.5 and 14 opinions.
“A lot of EFSA’s opinions are justified,” she observes, noting problems such as inappropriate target populations, bad references, confused endpoints and irrelevant studies.
She advocates the proprietary and emerging science route of article 13.5 for those claims that may have been dismissed under generic article 13.1, now that companies are, “armed with the knowledge of the high standard required to substantiate claims.”
Naturex President and CEO, Jacques Dikansky, said companies may need to consider other legislative avenues for claims approval such as the Traditional Herbal Medicinal Product Directive (THMPD), under which the company has submitted about 15 dossiers.
“They have all been approved or are under study,” he says of the 15. “We feel that it is a good way to go around some difficulties we can have with the claims.”
Jaap Kluifhooft, the Director of Regulatory Affairs at Lipid Nutrition, highlights the business impact of the health claims regulation.
“What we are seeing is a lot of reluctance with customers moving forward with product development, with innovations, because they are all awaiting the EFSA evaluations,” he says, gaining agreement from Dikansky. “Despite the fact the evaluation is not yet finished it is already affecting innovation.”
Kluifhooft’s company is a conjugated linoleic acid (CLA) specialist, and he notes there are about 70 CLA article 13.1 claims due for EFSA adjudication in February, 2010.
“We are confident the claim for CLA will come through because there is well-established science behind it,” he says.
Further insights into the European health claims situation can be found at the NutraIngredients Health Claims 2010 conference to be held in Brussels on 10th December. The likes of Provexis, Danone and Unilever as well as controversial US lawyer, Jonathan Emord, will be there to discuss the regulation. For more information and to register, please click here .