Miyarisan Applies for Novel Food Approval for Clostridium Butyricum

19 Mar 2013 --- A Japanese company has applied to the Food Standards Agency for approval to market a strain of the bacterium Clostridium butyricum as a novel food ingredient for use in food supplements. Views are wanted on the draft opinion prepared by the FSA's independent committee of experts.

The company, Miyarisan Pharmaceutical Co., plans to market Clostridium butyricum (strain CBM 588) as a probiotic food supplement. The bacterium would be produced as spores in tablet form. Any claims relating to probiotic function were not assessed during this safety evaluation, and will need to be assessed separately under the EU Nutrition and Health Claims Regulation.

Some species of clostridium are found in human and animal gut as part of the normal microflora.

The applicant has marketed preparations of this strain for use as a probiotic in Japan and other Asian countries for several decades and is now intending to market these supplements in the European Union (EU). The strain has also received EU approval as a microbial feed additive for chickens and piglets.

A novel food is a food or food ingredient that does not have a significant history of consumption within the European Union before 15 May 1997.

Before any new food product can be introduced on the European market, it must be assessed rigorously for safety. In the UK, the assessment of novel food is carried out by the Advisory Committee on Novel Foods and Processes (ACNFP).

The Agency is inviting comments on this draft opinion with a deadline of Thursday 28 March 2013.

The comments received will be passed to the committee before it adopts its final opinion on this novel food ingredient.