Newsletter
Ministry of Health and Welfare Announces the Amendments to the Regulations on the Recall and Destruction For Food and Related Products
The Regulations on the Recall and Destruction For Food and Related Products ("Recall and Destruction Regulations") have undergone two amendments since their initial promulgation on February 16, 2012; however, it has been over ten years since the last amendment. In order to strengthen the self-management capabilities of food operators and to facilitate the prompt recall of problematic products, thereby ensuring effective management of product hygiene and safety, the Ministry of Health and Welfare previously announced the draft amendments to the Recall and Destruction Regulations on May 22, 2025 to solicit public comments. The amended regulations were then officially promulgated on February 3, 2026, and have taken effect since the date of promulgation.
After the promulgation and implementation of the Recall and Destruction Regulations, in the event that foods, food additives, food utensils, food containers or packaging and food cleansers (hereinafter collectively referred to as the "Products") are found by the local competent authority, as per Article 41 of the Act Governing Food Safety and Sanitation, through inspection or examination to fall under any of the circumstances set forth in Items 1 to 3, Paragraph 1, Article 52 thereof, the manufacturers, sellers, or importers of such Products (hereinafter collectively referred to as the "Responsible Operators") shall, in accordance with the orders of the local competent authority and the amended Recall and Destruction Regulations (the "Amended Regulations"), carry out the recall and/or destruction procedures. The key points of the amendments are as follows:
I. Amendment and Introduction of the Establishment of Standing Task Force within the Responsible Operators and the Duties Thereof
The Amended Regulations stipulate that Responsible Operators must establish a "standing" task force, which shall be responsible for the following matters: (1) the initiation of the recall and destruction process; (2) the formulation, submission to the competent authority for record, and implementation of the action plan for the recall and destruction of Products under Article 3; and (3) the submission of the report on the recall progress under Article 5, among which Item 3 is a duty newly introduced by the amendments.
II. Amendment and Introduction of Items and Preservation Methods Required in the Product Recall and Destruction Plan
For the purpose of carrying out the recall and destruction procedures for the Products, Paragraph 2, Article 3 of the Amended Regulations stipulate that Responsible Operators must establish an action plan regarding Products recall and destruction, which shall include all detailed items related to the recall. The action plan is required to be preserved in written or electronic form.
Item 5 is a newly introduced provision. Certain items have been removed due to their duplication with Paragraph 2, Article 52 of the Act Governing Food Safety and Sanitation.
III. Amendment and Introduction of Methods and Frequency for Reporting Recall Progress
The Amended Regulations provide that Responsible Operators, except where their violations constitute non-compliance with labeling requirements as set forth in Item 3, Paragraph 1, Article 52 of the Act Governing Food Safety and Sanitation, shall report the recall progress in accordance with the frequency and methods (including through the electronic system designated by the central competent authority) prescribed by the local competent authority. The matters to be included in the aforesaid report are also enumerated in the amendments.
IV. Amendment and Introduction of Provisions Regarding the Supervision by Local Competent Authorities of Responsible Operators in Carrying Out Product Recall and Destruction Procedures
The matters pertaining to the supervision by local competent authorities of Responsible Operators in carrying out Products recall and destruction procedures include, among others: prescribing the frequency and method(s) by which Responsible Operators report the progress of recall; inspecting the initiation of Products recall procedures by Responsible Operators; inspecting the implementation of the aforementioned matters by Responsible Operators; verifying the accuracy of reports regarding the progress and completion of Products recall and destruction.
Given that the Recall and Destruction Regulations are intended for the competent authorities to supervise Responsible Operators following the initiation of recall procedures by the Responsible Operators, rather than to extend to inspections or examinations conducted prior to the initiation of recall procedures in accordance with the Act Governing Food Safety and Sanitation, Item 1, Paragraph 2, Article 4 of the Recall and Destruction Regulations was therefore removed. Items 2, 3, 8, and 10 have also been deleted for the following reasons: the addition or removal of other provisions in the Recall and Destruction Regulations; their lack of direct relevance to the supervisory responsibilities of the competent authorities; or their inclusion being solely for declaratory purposes.
V. Other Amendments
1. Placement of Recalled Products and Their Inventory
TheAmended Regulations provide that Responsible Operators must effectively separate and clearly label the recalled Products and their inventory from other raw materials, semi-finished products, and finished products.
2. New Provision regarding Electronic Notification Method
In order to protect consumer rights and ensure that problematic Products can be removed from shelves at an early stage, the competent authority may notify Responsible Operators by electronic means. The Responsible Operators or their agents shall, upon receiving the notification, implement the plan regarding the report on recall progress.
3. New Provision regarding Retention Period for the Recall and Destruction Records
The Amended Regulations require that records of Products recall be retained in paper or electronic form for at least five years.
4. Deletion of Articles 5, 6, Paragraph 1 of Article 8, Articles 9, 10, and 12
Considering that the matters regulated under Articles 5, 6, and 12 of the Recall and Destruction Regulations have already been stipulated in Articles 52 and 53 of the Act Governing Food Safety and Sanitation, these provisions are therefore removed.
It is noteworthy that Paragraph 1, Article 8 of the Recall and Destruction Regulations previously provided that Responsible Operators shall, based on the degree of health (or fatal) risk the Products may pose to the public, determine the recall level in accordance with the three categories set forth therein to conduct the recall. Article 10 further set forth the conditions under which the recall shall be disseminated through a press release for each recall level. Meanwhile, Article 9 of the Recall and Destruction Regulations classified the depth of recall into three levels: "consumers", "retailers", and "wholesalers". Given that Article 52 of the Act Governing Food Safety and Sanitation already stipulates the circumstances in which Products shall be recalled or destructed (that is, upon discovery of Products subject to recall under Items 1 to 3, Paragraph 1, Article 52, the local competent authorities shall order the Responsible Operators to forthwith announce cessation of use or consumption, and proceed with recall and destruction procedures), Paragraph 1 of Article 8, and Articles 9 and 10 of the Recall and Destruction Regulations are therefore removed.
Should industry participants require further analysis regarding the regulatory framework of the recall and destruction for food, our firm has established a "Life Sciences and Healthcare Practice Group", and we welcome you to contact our professionals for further assistance.