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. Status: Authorised


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. 

Legal Background

Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).

One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.

Application Status: Authorised

On the 2 February 2012, the company Miyarisan Pharmaceutical Co. Ltd made a request to the c to place Clostridium butyricum (CBM 588) on the market as a novel food ingredient to be used in food supplements. It was reviewed by the Committee to assess it whether the proposed use met the requirements under the regulation. Namely that it is safe, not misleading and would not put consumers as a nutritional disadvantage.

The Committee completed its assessment and published its positive opinion. This opinion was shared with the other Member States resulting in the product being authorised by the EU subject to the conditions specified in the authorisation. It was authorised under COMMISSION IMPLEMENTING DECISION (2014/907/EU).

Application Files