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[Updated] South Korea Issues Products Risk Assessment Act

The Act of Risk Assessment of Products for Human Body  came into effect on January 28, 2022. The enforcement decree and enforcement rule are released to specify the requirements of establishing the risk assessment board, and conducting the assessments. 

On July 27, 2021, the Ministry of Food and Drug Safety (MFDS) rolled out a new act named Act of Risk Assessment of Products for Human Body1. This act is to comprehensively manage the risks of the products directly applied to human body. The competent authority introduced that in the past, they individually conducted the risk assessment on food, cosmetics, drugs, and sanitation supplies, etc., which resulted in potential danger of consumer exposure to health risk when using multiple products at once. Therefore, MFDS established the new risk assessment mechanism to control the safety of Fast Moving Consumer Goods (FMCG). 


1. Products Subject to Risk Assessment

The scope of products for human subject to the risk assessment include:

Cosmetics specified in Cosmetics Act2

Food, food additives, food utensils, food container/packaging specified in Food Sanitation Act3

Agricultural and fishery products specified in Agricultural and Fishery Products Quality Control Act4

Livestock products specified in Livestock Products Sanitary Control Act5

Alcoholic beverages specified in Liquor Tax Act6

Health functional food specified in Health Functional Foods Act7

Pharmaceuticals, preparations, and quasi-drugs specified in Pharmaceutical Affairs Act8

Narcotics specified in Narcotics Control Act9

Medical devices specified in Medical Devices Act10

Hygiene products specified in Hygiene Products Act11

Other products specified by MFDS

2. Risk Assessment

MFDS can conduct a risk assessment of the above products under any of the following circumstances:

(1) The product poses a risk to human health and is prohibited from manufacturing/selling by an international institution or a foreign government;

(2) The product uses new ingredients or adopts new technologies, and for which the safety standards and specifications have not been established;

(3) The consumer requires a risk assessment on a product following the act;

(4) Other situations when the product is recognized as likely to harm human health.

The risk assessment items include:

(1) Reviewing the health-based guidance value;

(2) Identifying the harmful factors such as toxicity in human body;

(3) Caculating the harmful factor exposure of each product applied to human body;

(4) Comprehensive risk assessment of hazardous factors.

MFDS can have public officials enter the business place to inspect facilities, documents, etc., when necessary. To protect public safety, the authority can also temporarily suspend the sales of the relevant products and disclose the risk assessment results to the public.


ChemLinked Notes

Although the detailed assessment and investigation measures haven't been published, ChemLinked anticipates that the subordinate regulations will specify more details about the risk assessment measures and enterprises' obligations. We will keep you informed when the follow-up regulations are revealed. Stay tuned to ChemLiked.

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