Translated by Baker & McKenzie Attorneys-at-Law, Taipei.
Edited by Department of Health.
DOH Food No. 89002358 Promulgated, January 14, 2000
I. Purpose
These Food Recall Guidelines are established to provide a guide for carrying out food recall in order to ensure the hygiene, safety and quality of food and to protect health of citizens.
II. Scope
These Guidelines apply to the recall of food, which will or probably will cause hazard to the diet safety of the public or, whose quality does not conform to regulations.
III. Definition
1. Recall:
An express and organized measure adopted by the responsible entity to remove the same lot of food governed by the Guidelines from consumers, retailers or wholesalers.
2. Recall plan:
An action plan in writing or in other verifiable form devised by the responsible entity recalling food.
3. Entity:
Food businesses manufacturing, processing, preparing, selling, transporting, storing, importing or exporting food in connection with food recall.
IV. Initiation of Food Recall
1. The responsible entity shall proceed with recall where the food:
(1) by law shall be recalled for violating hygiene or other applicable regulations; or
(2) is of defect that it is deemed necessary for a recall.
2. Food recall is initiated under the following two circumstances:
(1) Where an entity launches the recall on its own initiative as required by law or where it deems recall necessary; and
(2) Where the competent health authority orders the entity by law to conduct the recall.
V. Classes and Levels of Recall
1. Recall is divided into the following three classes subject to the degree of harm the food causes to public health:
(1) Class 1: The food is expected to have a probability to cause death or serious harm to public health.
(2) Class 2: The food is expected to have a low probability to cause harm to public health.
(3) Class 3: The food is expected not to cause harm to public health but is not in conformity with the quality regulations.
2. Recall is divided into the following three levels depending on the extent sales channels are involved in food recall:
(1) Consumers: to the extent of individual consumers.
(2) Retailers: to the extent of sales premises.
(3) Wholesalers: to the extent of importer and wholesaler premises etc. where the food is not directly sold to consumers.
VI. Operation of Recall System
1. An entity shall set up an appropriate team to assess the timing for recall, formulate a recall plan, supervise the recall, and assemble data and report on the completion of recall. The convener of such team shall be the person with major responsibility for products and call the relevant departments to take action upon the occurrence of a cause for recall.
2. An entity shall establish complete and accurate production and sale records covering, inter alia, the name, weight, volume and lot number of the food concerned, name and dress of consignee, and date and quantity of delivery, as basis for the recall.
3. An entity shall devise a recall plan at least covering, inter alia, the following information:
(1) Product name, packaging, form, or special distinguishing features or signs of the food to be recalled;
(2) Date, lot number, code, or other identifying information and number specified on the food to be recalled;
(3) Name, address and telephone number of the responsible entity of the food to be recalled;
(4) Reason of the recall and nature of the potential hazard;
(5) Total production volume of the food to be recalled;
(6) Total volume of the food to be recalled in the sales channel;
(7) Distribution record of the food to be recalled;
(8) Recall measures to be adopted, including the level of recall, instruction on stopping the sale of the particular food, and other actions which shall be taken, prescribed time limit for the recall, etc.;
(9) Subsequent safety or destruction measures to be adopted, for instance, sterilization, recondition or correction etc.; and
(10) Warning which shall be issued to consumers, and the contents thereof.
4. In the event of a Class 1 recall, the recall plan of the responsible entity shall specify the recall being extended to the consumer level and such entity shall issue a press release. In the event of a Class 2 or 3 recall, the responsible entity initiating the recall shall propose the level of recall taking into consideration the nature of the potential hazard caused by the food to public health, and report to the local competent health authority prior to finalizing the recall proposal according to the instructions of such authority.
5. An entity shall present its recall plan to the local competent health authority for the file and, where necessary, issue a press release, prior to the recall of food.
6. An entity shall submit periodic progress reports to the local competent health authority in the course of food recall, covering at least the following information:
(1) Number of downstream entities or individuals being notified, and date and manner of notification;
(2) Number of entities responding to the notification and quantity of the particular food in their possession;
(3) Number of companies or individuals not responding to the notification;
(4) Quantity of recalled food;
(5) Number of times and result of investigation; and
(6) Anticipated time limit for completion.
7. An entity shall, upon completion of food recall, report the process and result of the recall in writing to the local competent health authority and, where necessary, to the central competent health authority, for placing the matter on the file for future reference.
8. An entity shall properly retain complete documentation on food recall for inspection and verification.
VII. Responsibilities of Government Authority
1. The local competent health authority shall supervise the recall by an entity and inspect the entity’s capability of recall. The work of such authority shall include the following:
(1) inspect the violating food, take action by law, and advise the entity to recall such food;
(2) give instruction on the class and level of the recall proposed by the entity, and file the entity’s recall plan for future reference;
(3) request the entity having submitted an incomprehensive recall proposal to make improvement;
(4) give instruction on the frequency of reporting the condition of recall, subject to the urgency of the case, and monitor the entity’s recall progress;
(5) supervise the entity in its completion of recall;
(6) assess the entity’s recall report;
(7) offer follow-up guidance to the entity;
(8) conduct periodic inspections to ascertain the extent of recall accomplished; and
(9) file relevant recall information and issue the necessary press release.
2. The central competent health authority shall supervise the local competent health authority in the execution of the above work and, where necessary, may assess the relevant reports submitted by the entity and give instructions.