#Japan #Osaka #HACCP #Kunsei Club #Red Yeast Rice

Investigating HACCP Compliance: A Public Inquiry

On July 8, 2026, Kunsei Club, a company based in Okayama Prefecture, submitted a public inquiry to the Osaka City Health Center and the Ministry of Health, Labor and Welfare's HACCP Promotion Office. This inquiry seeks to determine whether the administrative response to health issues relating to Kobayashi Pharmaceutical's red yeast rice products aligns with HACCP principles. The deadline for their response is set for July 22, 2026.

Background of HACCP Implementation

The introduction of the revised Food Sanitation Act on June 1, 2021, made it mandatory for all food businesses to practice sanitary management based on Hazard Analysis Critical Control Point (HACCP) principles. This legislation requires food companies to conduct hazard analysis rooted in scientific evidence regarding raw materials and production methods, as well as to maintain verifiable records. As a meat product manufacturer, Kunsei Club has established and is operating a sanitation management system in accordance with this framework.

However, there remain concerns regarding the scientific validation of the raw materials and production methods of the products implicated in this health incident. The inquiry raises critical questions about the validity of the administrative responses issued regarding these products.

Key Points of the Public Inquiry

The inquiry issued by Kunsei Club addresses several vital points:

1. Raw Materials: Was there a specific identification and confirmation of the particular strain of the red yeast fungus, such as the bp-412 strain, used in the products considered as the cause of the health issues? Were public statements made based on this identification?

2. Production Methods: The manufacturing process for these products reportedly involved a cultivation period of 30°C for 4 days, followed by 22°C for 43 days, resulting in a total of 47 days. On what basis did the authorities determine this cultivation condition was appropriate for establishing critical control points or other management measures during hazard analysis?

3. Evaluation of Production Methods: What assessments were conducted to evaluate the differences in cultivation conditions—especially the prolonged period at 22°C—compared to standard practices in red yeast rice production? How did these variations impact potential hazards?

4. Understanding HACCP Philosophy: The HACCP framework presumes that risks vary greatly among different products and businesses; therefore, are management points defined based on individual scientific evaluations? Did the blanket statement issued on March 28, 2024, addressing 225 companies using red yeast rice take into consideration individual differences in raw materials and production methods?

5. Post-Incident Re-Evaluation: Even if the administrative response was taken as an emergency prevention measure, was there any subsequent re-evaluation of individual risks considering the differences in raw materials and methods? If this was not done, what were the reasons behind this decision?

These inquiries highlight critical issues regarding the adherence to HACCP guidelines and the scientific validation necessary for food safety. The implications of these questions extend not just to the implicated company but also to public health standards and practices in the food industry.

Company Overview

• - Name: Kunsei Club Co., Ltd.
• - Representative: Masaki Mori, Pharmacist and CEO
• - Location: 611-1 Maekata, Hayashima, Okayama Prefecture, 701-0303, Japan
• - Business Focus: Meat product manufacturing
• - Contact:

- Phone: 086-483-0602
- Email: [email protected]
- Website: kunsei.com

This inquiry is not only crucial for the parties involved but also pivotal for enhancing transparency and ensuring consumer trust in food safety regulations.