Was the scientific verification of "raw materials" and "manufacturing methods" required by HACCP conducted?

PR97

Was the scientific verification of "raw materials" and "manufacturing methods" required by HACCP conducted?

— Public questionnaire sent to Osaka City Health and Welfare Bureau and Ministry of Health, Labour and Welfare HACCP Promotion Office —

Kunsei Club Co., Ltd. (Hayashima Town, Tsukubo District, Okayama Prefecture, Representative Director: Masaaki Mori) sent a public questionnaire on July 8, 2026, to the Osaka City Health and Welfare Bureau and the Ministry of Health, Labour and Welfare HACCP Promotion Office, asking whether the administrative response to the health damage incident caused by Kobayashi Pharmaceutical Co., Ltd.'s red yeast rice-related products (hereinafter referred to as "the incident") was in accordance with HACCP principles. The deadline for response is July 22, 2026.

Background

On June 1, 2021, amendments to the Food Sanitation Act made HACCP (Hazard Analysis and Critical Control Points) based hygiene management mandatory for all food business operators. This requires food businesses to conduct hazard analysis based on scientific evidence for raw materials and manufacturing methods, and to create and retain verifiable records. Our company, as a manufacturer of processed meat products, has established and operates a hygiene management system in line with the purpose of this system.

On the other hand, judging from the administrative response in the incident, there is doubt as to whether the response was based on a scientific verification of the same level regarding the raw materials and manufacturing methods of the product identified as the cause.

Main Contents of the Public Questionnaire

[Regarding Raw Materials] Regarding the red yeast rice strain, which is a raw material of the product identified as the cause of the incident, was specific strain (e.g., bp-412 strain) identified and confirmed before public announcement or other actions were taken?

[Regarding Manufacturing Methods] The manufacturing method for the product in question is stated to be a cultivation process of 30°C for 4 days, and 22°C for 43 days (total 47 days). What is the basis for determining that the cultivation conditions could reasonably be set as critical control points (CCPs) or other control measures as a result of hazard analysis?

[Regarding Evaluation of Manufacturing Methods] What evaluation was conducted regarding the differences between the said cultivation conditions (especially the long-term cultivation of 22°C for 43 days) and normal red yeast rice food manufacturing processes, and the impact of those differences on hazards?

[Regarding the Philosophy of HACCP and Uniform Public Announcement (to the Ministry of Health, Labour and Welfare)] The philosophy of HACCP is to set control points based on individual scientific evaluations, assuming that the content and degree of risk differ for each business operator and product. Was the uniform public announcement on March 28, 2024, of 225 companies using red yeast rice as a raw material, preceded by an evaluation that took into account the individual differences in raw materials and manufacturing methods of each company?

[Regarding Post-Incident Re-evaluation] Even if the above actions were taken as emergency preventive measures during the investigation, were individual risk re-evaluations conducted afterward based on the differences in raw materials and manufacturing methods of each company, and were corrections and re-announcements made accordingly? If not, what is the reason?

Response Deadline

July 22, 2026 (Wednesday)

Company Profile

Company Name: Kunsei Club Co., Ltd.

Representative: Representative Director / Pharmacist Masaaki Mori

Location: 611-1 Maegata, Hayashima Town, Tsukubo District, Okayama Prefecture, 701-0303

Business Activities: Processed meat product manufacturing

TEL: 086-483-0602 Email: [email protected]

https://kunsei.com/archives/category/benikoji