Public Inquiry Sent to Four Government Agencies Regarding Industrial Mutant Strain (BP-412) in Kobayashi Pharmaceutical's 'Beni-Koji Choleste Help'

Kunsei Club Co., Ltd. (Hayashima-cho, Tsukubo-gun, Okayama Prefecture; Representative Director/Pharmacist: Masaaki Mori) has submitted a public inquiry to four organizations: the Osaka City Public Health Center, the Food Labeling Division of the Consumer Affairs Agency, the Food Safety Standards Review Division of the Consumer Affairs Agency, and the Food Surveillance and Safety Division of the Ministry of Health, Labour and Welfare. The purpose of this inquiry is to improve the transparency of food safety assessments and regulatory operations.

Background of the Inquiry

Regarding the 2024 red yeast rice incident, the BP-412 strain used in the manufacturing of Kobayashi Pharmaceutical's 'Beni-Koji Choleste Help' can be confirmed as a mutant strain based on Gunze Limited's public patent (JP2009095304A) and Kobayashi Pharmaceutical's official news release (July 17, 2018). This strain underwent mutation treatment using UV irradiation to enhance monacolin K production, making it fundamentally different from traditional food-grade red yeast rice.

Importantly, 'Beni-Koji Choleste Help' had no purification process and was a product made by encapsulating solid fermented matter derived from an industrial mutant strain. It had a structure where neither the millennia of food history typical of traditional fermented foods nor the purification/safety assessment frameworks of pharmaceutical manufacturing could be directly applied.

However, it has not been made clear in media reports or disclosed documents how the issue of this industrial mutant strain was considered in the 2024 administrative response.

Note that the Consumer Affairs Agency's council approved a draft interim summary regarding the definition of supplements and mandatory GMP (Good Manufacturing Practice) on June 9, 2026. This inquiry includes points relevant to these regulatory review discussions.

Inquiries

Responses were requested in writing from the four agencies regarding the following six points:

1. Consideration of industrial mutant strains: Did you grasp and consider that an industrial mutant strain (BP-412) was used in the manufacture of 'Beni-Koji Choleste Help' during the 2024 administrative response? How were the results recorded? 2. Equating as 'red yeast rice raw material': It may not be appropriate to refer to BP-412 and traditional red yeast rice by the same name. Concerns have been raised that they have different manufacturing purposes, mutation processes, and usage practices. Did you consider the validity of treating products made from industrial mutant strains as the same 'red yeast rice raw material' as food-grade red yeast rice when publicly announcing the 225 companies, including us? 3. Risk assessment of industrial mutant strains without purification: This is the core question. Did you evaluate the sufficiency of safety assessments for consuming fermented matter from industrial mutant strains over the long term without purification? Specifically, for the Osaka City Public Health Center, what scientific basis was used to confirm safety for HACCP compliance? Please disclose the evidence. 4. Comparison with the L-tryptophan incident: Was the 1989 Showa Denko L-tryptophan incident in the US considered in the 2024 response? 5. Comparison with EU Novel Food regulations: Under EU regulations, ingredients without traditional usage require pre-market assessment. If Japan had similar regulations, would this product have been subject to additional safety assessments? Please share your views. 6. Premise of administrative judgment: Was the administrative judgment (recall request, public announcement of company names) based on the fact that the BP-412 strain is an industrial mutant strain?