MFDS Promulgates Imported Food Inspection Orders

On Sept 26th, MFDS released Notice No. 2019-84 ^[1] promulgating the new regulation “Imported Food Inspection Orders”. According to Article 22 of Imported Food Law ^[2], the inspection authority is entitled to order business entities to submit to inspections of all imported food. This new regulation details the supervision of foods that pose a risk of containing non-compliant ingredients. The procedure and main content are detailed in the diagram below:

Overall Procedures

Main content

• Inspection Object:

1. contain substances that should not be detected in food products, regulated in Article 3 of Part 2, Food Code ^[3]

2. contain pharmaceutical ingredients or similar ingredients used in treatment agents for erectile dysfunction, obesity, diabetes, etc.

3. contain synthetic additives that are not listed in Food Additive Code ^[4]

4. are named by MFDS director when a certain imported food repeatedly fails to comply with the stipulations of Article 21 and Article 25 of Imported Food Law

5. are named by the MFDS director when a certain imported food poses a hazard or may pose a hazard domestically or internationally.

• Inspection Procedures

Only testing institutions and inspection agencies regulated in Food and Drug Inspection Law ^[5] are qualified to conduct the imported food inspection.

• Fulfillment Procedures

After receiving the inspection order, business entities (including importers) shall turn to the testing institutions and inspection agencies regulated in Food and Drug Inspection Law to conduct the food inspection. Once the product is compliant, business entities shall submit the testing and inspection result issued by the testing institutions and inspection agencies to local FDA authorities.

In cases where a business entity cannot fulfill the inspection order, grounds shall be submitted to MFDS to prolong or cancel requirements to fulfill the inspection order.

• Reporting Procedures

• Conditions to cancel the inspection order

1. The validity period of the inspection order ends (depending on food types)

2. Starting from the day received the inspection order, all inspection items of 300 batches of food are all compliant

3. Starting from the day received the inspection order, the inspection items are compliant within 2 years

4. Other situations regulated by MFDS