Regulatory Affairs (RA)

Following a long tradition of documenting the effects and safety of Probi’s unique probiotic bacteria on a high scientific level, in November 2003 ProViva (containing Probi’s Lactobacillus plantarum 299v bacterium) became the first probiotic product outside Japan to receive official approval from an authoritative body (the Swedish Nutrition Foundation) to be marketed with a product-specific health claim.

Regulations relating to health claims have been harmonised in the European Union in accordance with EU Ordinance no. 1924/2006, with the European Food Safety Authority (EFSA) evaluating scientific documentation and previous product specific claims are no longer valid. Probi’s objective is to obtain governmental approval for a number of specific health claims and gain exclusive rights for as many of these as possible on the basis of clinical documentation.