“Currently, there is a gap between the point where the biomedical science ends (with the publication of a paper in a scientific journal) and the point where the business begins (with the claim for a health benefit).”
So say probiotic academics writing in a 2011 edition of the Britiish Jounral of Nutrition that reiterates criticism of the European Food Safety Authority (EFSA) mass rejection of probiotic gut and immunity claims under the Europan Union nutrition and health claims regulation (NHCR).
Led by Ger Rijkers, PhD, from the Department of Surgery at the University Medical Center Utrecht in the Netherlands, the position paper criticises the NHCR for failing to meet its objectives, and calls on greater dialogue among all stakeholders in the process from academia to business to regulators.
“…the objectives of the regulation are invalidated with respect to probiotics: rejection of all claims does not improve consumer protection, hinders cross-border movements of goods, has a negative impact on the willingness of companies to invest in research and development, and does not stimulate fair competition,” they write.
“Most importantly, the objective of protecting consumers is not met. The consumer does not receive adequate information on probiotics, in which a considerable amount of research and development has been invested.”
Knowledge gaps and ‘regulatory science’
Rijkers and co. highlight some of the gaps that need filling in research terms to meet EFSA requirements such as showing benefits in healthy populations, strain characterisation and defining clinical endpoints.
“… emphasis on the physical interaction of probiotic bacteria with relevant receptors on cells of the
immune system will be important to bring additional evidence on the underlying mechanisms of immunoregulatory effects
of probiotics,” they counsel.
“Regulatory science that links the regulatory requirements of (in this case) probiotic product development to the science that ensures safety and functionality of probiotics will be needed to close this gap.”
“Because health claim approval requires both regulatory and basic sciences, both disciplines would benefit from a dialogue.”
British Journal of Nutrition
‘Health benefits and health claims of probiotics: bridging science and marketing’
Authors: Ger T. Rijkers, Willem M. de Vos, Robert-Jan Brummer, Lorenzo Morelli, Gerard Corthier, Philippe Marteau
Pre- and Probiotics 2012 Virtual Conference and Expo
Cutting edge health conditions for probiotics will be discussed at the NutraIngredients Pre & Probiotics virtual conference on February 1, 2012. More details here .