South Korea Implements Regulations on Hazard Assessment of FMCGs

Potentially hazardous food (and other products generally considered fast moving consumer goods) as designated by international institutions or foreign governments, which use new ingredients, use new technologies or do not have a clear safety standard are required to undergo hazard assessment.

On 17^th April, 2019, South Korea amended and implemented Regulations on Hazard Assessment of Human Applied Products ^[1]. The regulation is applicable to products that can be contacted, inhaled or absorbed by human beings such as cosmetics, food, pharmaceuticals, etc. in South Korea.

The main amendments are as follows:

1. The regulation name is changed. The regulation's name is changed from "Regulation on Hazard Assessment Methods and Procedures" to "Regulation on Hazard Assessment of Human Applied Products". The scope of objects required hazard assessment is expanded to human applied products, which include:

Food, food additives, food utensils, container/packaging specified in Food Sanitation Act ^[2]

Health functional food specified in Health Functional Foods Act ^[3]

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

Livestock products specified in Livestock Products Sanitary Control Act

Cosmetics specified in Cosmetics Act

Pharmaceuticals, preparations and quasi drugs specified in Pharmaceutical Affairs Act

Medical devices specified in Medical Devices Act

Hygiene products specified in Hygiene Products Act

Other products specified by MFDS

Among them, the products which require hazard assessment are:

1) Human applied products pose a risk to human health as established by international institutions or foreign government and are prohibited from manufacturing/selling
2) Human applied products that use new ingredients, adopt new technologies, or do not have safety standards
3) Other human applied products that may do harm to human health

MFDS plans to formulate a list of 60 hazardous substances with high risks and will give priority to conduct comprehensive hazard assessment of those substances by 2020 ^[4].

2. Hazard Assessment Committee is established.

Hazard Assessment Committee is established to provide consulting services. The consultation scope includes, 1) hazard assessment methods, 2) cross-checking of hazard assessment results, 3) procedures and methods of toxicological tests, etc.

3. The methods and procedures of comprehensive hazard assessment are clarified and toxicological tests’ methods and procedures of hazardous substances in human applied products are newly added.