South Korea enacts the Act on Risk Assessment of Products for Human Body

South Korea enacted the Act on Risk Assessment of on July 27, 2021. This Act aims to protect and promote public health by evaluating risk assessment of products applied to the human body and regulating matters of safety management.

The Ministry of Food and Drug Safety (MFDS) will examine risk assessment of various products and channels to understand the overall impacts and risk factors of products applied to the human body. MFDS will also establish and implement a master plan on risk assessment of products applied to the human body every five years, following deliberation by the risk assessment policy committee, to manage risk assessment systematically and effectively.

Products applied to the human body include 11 categories as follows:

• Foods, food additives, equipment, container and packaging defined in ˹Food Sanitation Act˼
• Agricultural and marine products and processed foods defined in ˹Agricultural and Fishery Products Quality Control Act˼
• Livestock defined in ˹Livestock Products Sanitary Control Act˼
• Liquors defined in ˹Liquor Tax Act˼
• Health Functional Foods defined in ˹Health Functional Foods Act˼
• Medicine, herbal medicine, ingredients of herbal medicine and quasi-drugs defined in ˹Pharmaceutical Affairs Act˼
• Narcotics defined in ˹Narcotics Control Act˼
• Cosmetics defined in ˹Cosmetic Act˼
• Medical Devices defined in ˹Medical Devices Act˼
• Hygiene Products defined in ˹Hygiene Products Control Act˼
• Other products controlled by the Minister of Food and Drug Safety based on Presidential Decree

This comes into effect from January 28th, 2022.