Who Is Responsible for the Zhonglian Carcinogenic Oil Incident? FDA Announces Investigation Results! 'The Source Is Here' – 3 Key Management Failures Identified

The Food and Drug Administration (FDA) of Taiwan's Ministry of Health and Welfare officially announced today (27) the third-party independent investigation results of the 'Zhonglian Oils case.' After an expert team conducted on-site inspections at the factory and comprehensive analysis, it was confirmed that the benzopyrene (BaP)超标 was not due to a single factor, but rather the combined effect of three major management failures: 'high-risk raw material management,' 'process control,' and 'inspection and monitoring.' In particular, some soybean raw materials imported from Brazil were identified as higher risk, although no direct evidence was found that the processing equipment itself generated benzopyrene.

Root Cause of Benzopyrene超标 in Zhonglian Oils Soybean Oil Revealed! Independent Investigation Uncovers '3 Major Management Failures,' Brazilian Soybeans Identified as Higher Risk

The FDA commissioned the 'Food Industry Research and Development Institute' to establish an independent investigation team composed of experts in food science, food technology, and law. On July 21, the team entered Zhonglian's factory to conduct a comprehensive review of its manufacturing and quality management processes.

Based on analysis of existing test data, the investigation team pointed out the following:

1. Raw Material Risk Variability: Soybean oil extracted from Brazilian-imported soybeans was more likely to test positive for benzopyrene compared to oil made from U.S.-imported soybeans.

2. Quality Control Gaps: Despite known quality differences between raw material shipments, the company did not strengthen risk controls, increase inspection frequency, or implement preventive measures such as process adjustments for higher-risk raw materials, ultimately leading to benzopyrene超标 in the final product.

3. Failure to Implement Process Monitoring and Corrective Actions: No direct evidence was found that the processing equipment generated benzopyrene. However, multiple process parameters violated quality control limits, and timely corrective and improvement measures were not taken. Additionally, the company lacked a dynamic process adjustment strategy to respond to risks.

No Direct Evidence of Benzopyrene Generation from Equipment! But Multiple Quality Control Violations and Lack of Timely Corrections

Regarding concerns about equipment, the investigation team confirmed no direct evidence that the processing equipment generated benzopyrene. However, Zhonglian Oils had significant oversights in process management, with multiple process parameters failing to meet quality control standards. When issues arose, corrective and improvement measures were not promptly implemented, and there was no dynamic process adjustment mechanism in place to respond to risks.

Furthermore, within its food safety management system, the company failed to fully identify, assess, and manage chemical hazard risks such as benzopyrene. It even relaxed quality control standards for high-risk raw materials and did not increase inspection frequency for raw materials or finished products, resulting in a complete breakdown of risk prevention.

Executive Yuan Submits Draft Food Safety Law Amendments Focusing on Five Areas: Strengthening Source Control and Digital Governance

The FDA emphasized that to prevent similar major food safety incidents from recurring, the Executive Yuan passed amendments to the 'Food Safety and Sanitation Management Act' on July 23 and formally submitted the draft to the Legislative Yuan for review.

The key focus of this legislative revision centers on five reform directions: source management, process management, anomaly reporting, quality management, and digital governance. The FDA stated that it will adopt professional recommendations from the third-party investigation team to continuously improve Taiwan's food safety management system, strengthening source, process, and quality controls through regulations to comprehensively enhance early warning capabilities for food safety risks.

Q1: What was the main cause of benzopyrene超标 in Zhonglian Oils' soybean oil? Was it equipment contamination?

A: According to the third-party investigation report, no direct evidence was found that the equipment generated benzopyrene. The超标 was primarily due to the combined effect of three major management failures: 'high-risk raw material management,' 'process management,' and 'inspection and monitoring.'

Q2: What are the high-risk raw materials mentioned in the investigation report?

A: Test data shows that soybean oil made from 'Brazilian-imported soybeans' is more likely to test positive for benzopyrene compared to 'U.S.-imported soybeans,' and there are quality differences between different shipments of raw materials.

Q3: What preventive measures has the government taken at the regulatory level in response to this incident?

A: The Executive Yuan has passed the draft amendments to the 'Food Safety and Sanitation Management Act' and submitted it to the Legislative Yuan. The focus is on five areas: source management, process management, anomaly reporting, quality management, and digital governance, aiming to establish an early warning mechanism.