Clostridium butyricum (strain CBM 588). EC No. 132

February 2012: Application from Miyarisan Pharmaceutical Company, Japan for the authorisation of the bacterium Clostridium butyricum CBM 588 as a food supplement under the Novel Food Regulation (EC) 258/97. Under evaluation.

Clostridial species can be found in the gut of humans and animals as part of the normal gut microflora.

The applicant’s intention is to market Clostridium butyricum (strain CBM 588) as viable spores in tablet form. The applicant states that the novel ingredient is intended for use as a probiotic food supplement. 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.

The applicant has marketed preparations of this non-pathogenic 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 EU. This strain of Clostridium butyricum has also received EU approval as a microbial feed additive for chickens and piglets.

The ACNFP has considered this application and has prepared a draft opinion.

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

Any comments on this draft opinion should be sent to the ACNFP Secretariat by 28 March 2013 and will be passed to the Committee before it adopts its final opinion of this novel food ingredient.