EU Concludes Bacillus coagulans DSM 32789 Is a Novel Food

The European Commission has finalized its consultation on the novel food status of Bacillus coagulans DSM 32789, a bacterial strain proposed for use in food supplements. Following a review of the available data on its history of use and production, it was concluded that this strain qualifies as a novel food under Regulation (EU) 2015/2283. The decision was based on the fact that no significant evidence of its consumption within the EU before 15 May 1997 could be demonstrated. As a result, the strain will require formal novel food authorization before it can be legally marketed in the EU. The consultation outcome applies specifically to this strain and its intended use in food supplements. This clarification informs food business operators about the regulatory requirements for introducing this probiotic strain into the EU market.