Foods for Medical Purpose are Subject to Food Traceability Management in South Korea

The food for women during pregnancy or lactation, food for special medical purpose, and food for regulating weight, whose sales is over 100 million won, will be subject to the food traceability management requirements in South Korea from December 1, 2021. ChemLinked presents MFDS’ phased management schedule and the registration process for enterprises' reference.

On February 3, 2021, MFDS specified that certain imported FSP (Foods for Special Purpose) should comply with the food traceability requirement from December 12 this year. ¹ The FSP foods subject to the food traceability requirements are food for women during pregnancy or lactation, food for special medical purpose, and food for regulating weight, whose sales is over 100 million won (about 89.5 thousand USD) in 2016 respectively.

Background Introduction

Food traceability is one critical part of selling food in South Korea. It requires enterprises to report the food safety information from the manufacture to the distribution. The information of the imported food to report include:

Traceability number of the imported food
Import enterprise's name and address
Manufacturing country
Manufacture enterprise's name and address
GM Food label (if any)
Date of production
Expiration date
Import date
Raw materials or ingredient list
Recall information

Food traceability requirements of FSP products in South Korea

FSP in South Korea includes:

Formula milk powder
Formula diet for newborns
Formula diet for babies during weaning
Food for women during pregnancy or lactation
Food for special medical purpose
Food for regulating weight

MFDS manages the traceability of FSP through a comprehensive phased approach. In 2014 and 2016, South Korea specified the food traceability requirements for food for newborns and infants, as well as formula milk. The management on food for women during pregnancy or lactation, food for special medical purpose, and food for regulating weight was set to start from 2019:

Food Type	Standard	Enforcement Date
Food for women during pregnancy or lactation Food for special medical purpose Food for regulating weight	The sales amount for each food type in 2016 is over 5 billion KRW (about 4.475 million USD)	December 1, 2019
	The sales amount for each food type in 2016 is over 1 billion KRW (about 895 thousand USD), less than 5 billion KRW (about 4.475 million USD)	December 1, 2020
	The sales amount for each food type in 2016 is over 100 million KRW (about 89. 5 thousand USD), less than 1 billion KRW (about 895 thousand USD)	December 1, 2021
	The sales amount for each food type in 2016 is less than 100 million KRW, and the food sold by entities registered after 2017.	December 1, 2022

As MFDS stated, for the enterprises selling the relevant products for more than 100 million KRW, they should apply for the traceability since December 1, 2021. And the enterprises selling the relevant products for less than 100 million KRW, should apply for the traceability from December 1, 2022. By then, the phased management on all FSP foods is completed.

Following the guidance in Food Traceability System ², the application procedure is:

水印-1.png The application dossiers for the imported food include:

1. Application letter of the traceability management of the imported food

2. Manufactured food item report OR Import declaration certificate OR Purchase order

3. Traceability management plan

Consult with the author if you need compliance service.