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Announcement on Food Businesses That Should Conduct Inspections, Minimum Inspection Cycles, and Other Relevant Issues to Encourage Businesses to Emphasize Self-Management Responsibilities

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2014-08-21
  • Last Updated:2024-04-25

To strengthen the gatekeeper responsibilities of the food industry toward the raw materials within their products, semi-finished products, and finished products, the Food and Drug Administration (FDA), Ministry of Health and Welfare, in accordance with Paragraphs 3 and 4, Article 7 of the Act Governing Food Safety and Sanitation (referred to as the Food Safety Act below), announced the Food Businesses That Should Conduct Inspections, Minimum Inspection Cycles, and Other Relevant Issues on August 21, 2014. This announcement detailed the five major industries that should implement independent quality control based on the risk control principles and the spirit of the Hazard Analysis and Critical Control Points (HACCP) and set a date of December 31, 2014, for the implementation of mandatory inspections. 

If the primary raw materials of farmed animal origin used in processed meat, dairy, and aquatic foods contain residual veterinary drugs that do not conform to requirements and cannot be removed through subsequent processing, the final products often present safety hazards. In addition, management of food additive safety should be strengthened, and attention should be paid to products that contain special nutritional foods for patients and infants as these may be the sole sources of nutrients for these special and sensitive groups. Thus, the FDA announced the Food Businesses That Should Conduct Inspections, Minimum Inspection Cycles, and Other Relevant Issues, stipulating the following: 
1. Meat processing, dairy processing, and aquatic food plants that must satisfy the HACCP Guidelines should perform veterinary drug residue inspections for at least the primary raw materials of farmed animal origin that they use. 

2. Food additive manufacturers and importers should inspect at least raw materials, semi-finished products, and finished products with food additives for heavy metals, impurities other than heavy metals, and other sanitation management. 

3. Special nutritional food businesses should perform microbial and nutrient content inspections on at least finished special nutritional food products. 

The minimum inspection cycle described above is once per quarter. When the primary raw materials or finished products that should be inspected are imported or shipped less than once per quarter, they should be inspected by batch. Records of inspection results should be stored for six months after the quarter ends or after the expiration date of the products manufactured from the inspected items. 

The FDA emphasizes that inspections are not the only method of self-management. Inspections alone are not enough to prevent the occurrence of food safety incidents with maliciously added illegal ingredients. Food businesses should focus on their own responsibilities as producers and sellers of food and ensure that they satisfy the standards of production and sales management. Food businesses that must implement mandatory inspections in accordance with this announcement should themselves conduct or outsource further inspections. The results of these inspections can be compared and confirmed with inspection reports from suppliers to strengthen supplier management and to control the safety of the raw materials in products, semi-finished products, and finished products. 

Failure by businesses to conduct mandatory inspections will constitute violation of Paragraph 3, Article 7 of the Food Safety Act. In accordance with Article 48 of the same act, violators who fail to correct their violations within the prescribed time limit shall be fined between NT$30,000 and NT$3,000,000. In severe circumstances, the enterprise may be ordered to terminate business, suspend business for a certain period of time, revoke all or part of the items listed in the company registration, business registration, and factory registration, or revoke the registration of the food businesses. If registration of the food businesses is revoked, re-application for new registration shall not be permitted within one year.