Recalling harmful foods, etc.
Duty to recall harmful foods, etc.
- In the event where a business operator who manufactures, processes, subdivides, imports or sells foods, etc. for the purpose of sale comes to realize that such foods, etc. have violated Article 3 (Prohibition Against Sale, Etc. of Harmful Foods, Etc.), Article 5 (Prohibition Against Sale, Etc. of Meat, Etc. Affected by Diseases), Article 6 (Prohibition Against Sale, Etc. of Chemical Synthetics, Etc., Standards and Specifications which are not Prescribed), Article 7(4) (Standards and Specifications concerning Foods or Food Additives), Article 8 (Prohibition Against Sale and Use of Poisonous Apparatus, Etc.), Article 9(4) (Standards and Specifications concerning Apparatus, Containers and Packages), Article 12-2(2) (Labeling of Genetically Modified Foods, Etc.) or Article 4(3) (Labelling Standards) or Article 8(1) (Prohibition of False Labeling or Advertising) of the Act on Labelling and Advertising of Foods shall recall the concerned foods in distribution or enforce measures that are necessary for the recall without delay (Former part of Article 45(1) of the Food Sanitation Act and Article 58(2) of the Enforcement Regulations of the Food Sanitation Act, Article 15 of the Act on Labelling and Advertising of Foods).
※ Any business operator who fails to enforce recall measures in violation of this provision shall be subject to cancellation of business license and registration, business suspension and closure of business establishment (Subparagraph 14 of Article 75(1) of the Food Sanitation Act and Article 89 and Subparagraph 12 of attached Table 23-II-1 of the Enforcement Regulations of the Food Sanitation Act).
- However, where the relevant food, etc. is food, etc. imported pursuant to the Special Act on Imported Food Safety Control, and a person liable to make a report is an importer of the relevant food, etc., he/she shall report to the Minister of Food and Drug Safety (A provision of Article 45(1) of the Food Sanitation Act).
- The standards for the foods, etc. that are subject to recall are provided in attached Table 18 of the Enforcement Regulations of the Food Sanitation Act (Article 45(3) of the Food Sanitation Act and Article 58(1) of the Enforcement Regulations of the Food Sanitation Act).
Recall plans and procedures for harmful foods, etc.
- The particulars to be included in the recall plan are as follows (Article 45(3) of the Food Sanitation Act and Article 59(1) of the Enforcement Regulations of the Food Sanitation Act).
· Product name, manufacturing date, and use-by-date
· Planned amount to be recalled (calculated by taking into consideration the consumption amount and the use-by-date of the relevant foods, etc. when it was determined to be harmful foods, etc.)
· Reason for recall
· Method of recall
· Recall period and expected duration
· Disposal methods such as discarding, etc. of recalled foods, etc.
· Methods to inform the public of the recall
- In the event that a notifying office receives a recall plan from the business operator, the following actions shall be taken without delay (Article 59(2) of the Enforcement Regulations of the Food Sanitation Act).
· Inform the Minister of Food and Drug Safety of the recall plan. During this process, where the notifying office is the head of a Si/Gun/Gu, such notification shall be sent through the Mayor or Provincial Governor
· Order the concerned business operator to announce a recall plan pursuant to Article 73(1) of the Food Sanitation Act
· Carry out an inspection of recalled foods, etc. that are in circulation to verify relevant violation
- A business operator whohas reported a collection plan shall recall the concerned harmful foods,etc. and notify a notifying office of the outcome of such recall (Article 59(3)of the Enforcement Regulations of the Food Sanitation Act).
Reduction of and exemption from administrative disposition against business operators who recalled harmful foods, etc.
- Business operators who have faithfully implemented the necessary measures for the recall of harmful foods, etc. may be exempt from administrative dispositions pursuant to Article 75 or Article 76 of the Food Sanitation Act that are received for the relevant foods, etc. in the following manner (Article 45(2) of the Food Sanitation Act and Article 31 of the Enforcement Decree of the Food Sanitation Act).
· Where business operators recalled more than 4/5 of the planned amounts of foods to be recalled in accordance with a recall plan under the latter part of Article 45(1) of the Act: Exempt from administrative disposition for relevant violations
· Where business operators recall not less than 1/3 of planned amounts of foods to be recalled: Where the standard for administrative disposition (hereinafter referred to as "standard for administrative disposition" in this Article) under Article 75(4) or Article 76(2) of the Food Sanitation Act is the closure of business offices, measures of business suspension of more than 2 months but less than 6 months shall be taken; where the standard for administrative disposition is business suspension or the suspension of manufacturing items or kinds of items, the administrative disposition shall be reduced within the scope of not more than 2/3 of the suspension period
· Where business operators recall more than 1/4 but less than 1/3 of planned amounts of food recalls: Where the standard for administrative disposition is the closure of business offices, measures of business suspension of more than 3 months but less than 6 months shall be taken; where the standard for administrative disposition is business suspension or the suspension of manufacturing items or kinds of items, the administrative disposition shall be reduced within the scope of not more than 1/2 of the suspension period
Administrative contestation for business suspension measures
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Q. I was ordered to suspend my business while running a side dish store, and I strongly feel that I was wrongfully accused. Is there any solution to my case? A. A side dish store operator who has been subject to an administrative disposition may file an administrative appeal against a disposition or omission by an administrative agency (Article 3(1) of the Administrative Appeals Act), or file an administrative lawsuit at the court.
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Reporting on detection of foreign substances in foods, etc.
Duty to report on the detection of foreign substances in foods, etc.
- Where a business operator who has manufactured, processed, subdivided, imported or sold foods, etc. for sale receives a notification from consumers on the detection of substances (hereinafter referred to as "foreign substances"), other than raw materials or ingredients normally used in the process of manufacturing, processing, cooking or distributing foods, which are likely to endanger sanitation in the process of ingestion, or which are not suitable for ingestion, the business operator shall report such a fact to the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu without delay (Article 46(1) of the Food Sanitation Act).
※ A person who submits a false report after receiving a notification on the detection of a foreign substance from a customer or a person who falsely notifies the detection of a foreign substance in violation of this provision shall be punished by imprisonment for not more than
1 year or be subject to a fine not exceeding KRW 10 million (Subparagraphs 2 and 3 of Article 98 of the Food Sanitation Act). A person who fails to report entirely after receiving a notification on the detection of a foreign substance from a customer shall be subject to an administrative fine of KRW 3 million, KRW 4 million for the 2nd violation, and KRW 5 million for the 3rd or subsequent violations. A person who has delayed reporting the discovery of foreign substances shall be subject to an administrative fine not exceeding KRW 1 million (KRW 2 million and 3 million shall be imposed for the 2nd and 3rd violations, respectively) (Subparagraph 5-2 of Article 101(2) of the Food Sanitation Act and Article 67 and Subparagraph 2(r) of attached Table 2 of the Enforcement Decree of the Food Sanitation Act).
Subject matters, etc. to be reported as foreign substances
- Any of the following foreign substances shall be reported to the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu (Article 46(5) of the Food Sanitation Act and Article 60(1) of the Enforcement Regulations of the Food Sanitation Act).
· Materials in quality or in size that may cause direct harm or damage to the human body during the intake process, such as metallic foreign substances, glass fragments, etc.
· Substances that may be deemed repellent during the intake process, such as parasites and their eggs, carcasses of animals, etc.
· Other substances that may harm the health of the human body or are not suitable for consumption, as recognized by the Minister of the Food and Drug Safety
- Any person who intends to report on the discovery of foreign substances shall submit the supporting evidence such as photographs and relevant foods to the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu (Article 60(2) of the Enforcement Regulations of the Food Sanitation Act).