Japanese firm seeks EU probiotic approval
The application – the first time that a live microorganism has been assessed under the Novel Foods Regulation - targets Clostridium butyricum (strain CBM 588) to be used as a food supplement.
Miyarisan Pharmaceutical, which produces the bacterium as spores in tablet form, is marketing CBM 588 around its ability to “support, maintain or restore healthy gut flora physiology and/or function”.
The application from Miyarisan Pharmaceutical comes after several decades of marketing preparations of this strain for use as a probiotic in Japan and other Asian countries. It already has EU approval as a microbial feed additive for chickens and piglets.
In its application to the FSA’s Advisory Committee on Novel Foods and Processes (ACNFP), Miyarisan Pharmaceutical said CBM 588 fulfils the criteria of a novel food, namely ´foods and food ingredients consisting of or isolated from microorganisms, fungi or algae´, under the Class 2.2 category: ´complex novel food from non-GM source, the source of the novel food has no history of food use in the Community´.
Miyarisan Pharmaceutical says improvements in the gut may include improved gut transit time, improved faecal bulk and consistency, improved regularity and comfort of bowel movements and possibly reduction in risk factors associated with enteric disease.
History of use
The company claims preparations based on CBM 588 have a long history of safe use in Asia, especially in Japan, where such products are classified as pharmaceutical drugs or over-the-counter probiotics.
“The safe history of CBM 588 in human Asian populations is supported by various peer-reviewed publications and case studies dating back to 1963, including reports of CBM 588 use in severely-ill, immune-compromised and hospitalized patients, whose ages range from infants to elderly people, and include pregnant women,” says the report.
Miyarisan said there have been very few complaints in Japan (less than 0.1%), where it sells around 200,000 packs per year. The firm also quoted studies which tested the toxicity of CBM 588 on rats. In a study carried out by Yuzuwa et al, a high dose of 5,000 mg/kg body weight was given orally to rats.
No animals, however, showed any signs of toxicity or died during 14 days of observation, and there were no changes attributable to the administration of the test powder in body weight gain or clinical signs, it says. As well as viable spores of CBM 588, the tablets contain corn starch, lactose, hydrated magnesium silicate, microcrystalline cellulose, magnesium stearate and sucrose.
The tablets are made using a submerged anaerobic fermentation process, similar to that used in EU food production, for example for sauerkraut or vinegar.