Regulations of recall and destruction for food and related products
1.中華民國一百零一年二月十六日行政院衛生署署授食字第 1001304012 號令訂定發布全文 15 條;並自發布日施行 2.中華民國一百零二年八月二十日衛生福利部部授食字第 1021350146 號 令修正發布第 1、6 條條文 3.中華民國一百零四年八月十日衛生福利部部授食字第 1041302468 號令 修正發布第 1 條條文 4.中華民國一百十五年二月三日衛生福利部衛授食字第 1141302254 號令 修正發布全文 10 條;並自發布日施行
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These Regulations are established pursuant to Paragraph 3, Article 52 of the Act Governing Food Safety and Sanitation (the “Act”).
1The recall and destruction of food and related products (the “Products”) shall be conducted by the manufacturer, seller, or importer of the Products (the “Responsible Enterprise”).
2The Responsible Enterprise referred to under the preceding paragraph shall establish a standing task force responsible for the following matters:
31. Initiating recall and destruction procedures;
42. Formulating, submitting for recordation, and executing a recall and destruction plan for the Products as stipulated under Article 3; and
53. Submitting recall progress reports as stipulated under Article 5.
6The task force referred to under the preceding paragraph shall appoint one convener who, upon occurrence of the reason for recalling the Products, shall convene a meeting of relevant personnel to deliberate on the initiation and execution of the recall and destruction procedures.
1When executing the recall and destruction of the Products, the Responsible Enterprise shall establish a recall and destruction plan for the Products and retain it in written or electronic form.
2The content of the plan referred to under the preceding paragraph shall include the following information:
31. The name, address, and telephone number of the Responsible Enterprise;
42. The name, packaging, form, and/or other identifiable characteristics or symbols of the Products subject to recall;
53. The batch numbers, serial numbers, and/or other dates, symbols, marks, or codes sufficient to identify the Products subject to recall;
64. Information on the import, manufacturing, procurement, shipment, and inventory weight or volume of the Products subject to recall;
75. The name, address, and emergency contact telephone number of downstream counterparties as well as the shipment date, batch number and weight, or volume of the shipped Products;
86. The reason for the recall;
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The Responsible Enterprise shall effectively segregate and clearly label the recalled Products and their inventory from other raw materials, semi-finished products, and finished goods.
1The Responsible Enterprise shall, from the recall commencement date to the completion date, report the progress of the recall in accordance with the frequency and method designated by the competent municipality or county (city) authority.
2The reporting method referred to under the preceding paragraph may be done by logging the recall progress via the electronic system designated by the central competent authority.
3The report content referred to in Paragraph 1 shall include the following information:
41. The name, specifications, and expiration date of the relevant components of the Products at issue;
52. The production volume or procurement volume, inventory levels, volume of recall from downstream counterparties and volume of return to upstream counterparties, and volume of sales to downstream counterparties of the Products at issue and relevant components;
63. The date and method of notifying downstream counterparties to recall the Products;
74. The names and addresses of downstream counterparties; and
85. Other information designated by the competent authority as reportable.
1Documents served by the competent authority on the Responsible Enterprise or its agent may first be transmitted electronically to the electronic system designated by the central competent authority.
2The Responsible Enterprise or its agent shall, upon accessing the electronic system referred to in the preceding paragraph, implement the provisions of the preceding article.
The Responsible Enterprise shall report to and obtain approval from the competent municipality or county (city) authority before proceeding with the destruction of the Products.
1The competent municipality or county (city) authority shall supervise the Responsible Enterprise in executing the recall and destruction of the Products.
2The supervision referred to under the preceding paragraph shall include the following matters:
31. Designating the frequency and method for the Responsible Enterprise to report the progress of the recall;
42. Verifying the initiation of the Responsible Enterprise’s recall procedures;
53. Verifying the Responsible Enterprise’s implementation of the plan stipulated under Article 3 and the accuracy of the recall progress report as prescribed under Article 5;
64. Verifying the Responsible Enterprise’s completion of the final disposal of the recalled Products; and
75. Other matters designated by the central competent authority.
The Responsible Enterprise shall prepare complete records of the procedures and details of the Products’ recall and destruction, retaining them in paper or electronic format for at least five (5) years.
These Regulations shall take effect on the date of promulgation.
108. Storage location of the recalled Products and personnel responsible for the safekeeping thereof;
119. Final disposal of recalled Products:
12(1) For disinfection, reprocessing, or other appropriate safety measures: specify the methods and procedures adopted, along with the scheduled completion date; or
13(2) For destruction: specify the destruction method and timeframe, along with the weight or volume of destroyed Products; and
1410. Other matters designated by the competent authority for execution of the recall and destruction plan.
15The Responsible Enterprise shall submit the recall and destruction plan for the Products specified under Paragraph 1 to the competent municipality or county (city) authority for recordation.
9Paragraph 2 shall not apply to recalls required for the reasons listed under Subparagraph 3, Paragraph 1, Article 52 of the Act.