South Korea's Food and Drug Safety Agency Announces Explosive Revisions: Custom Health Food Market Faces Major Transformation!

On October 16, 2024, the Ministry of Food and Drug Safety (MFDS) officially issued a notice No. 2024-473, announcing a series of important amendments to the "Health Functional Food Related Law Implementation Rules". These amendments aim to further strengthen the standardization of the health functional food market, ensure the quality and safety of products, and better protect the rights and interests of consumers. The specific revisions are as follows:

1. Set the facility standards for the customized health functional food sales industry: In order to ensure the safety and compliance of the sales environment, the revised content adds the facility standards for the customized health functional food sales industry. These standards will cover the hygienic conditions of the sales premises, the temperature control of storage facilities, and the standardization of product display, so as to provide consumers with a safe and hygienic shopping environment.

2. Provisions for the compliance of customized health functional food sales operators: The revised content clarifies the matters that customized health functional food sales operators must comply with in the business process. These matters include but are not limited to product quality control, the accuracy of label information, and the guarantee of after-sales service, etc., to protect the rights and interests of consumers and the quality and safety of products.

3. Newly set safety management and sales standards for packaging and combination: In order to ensure the safety and compliance of products in the process of packaging and combination, the revised content adds safety management and sales standards for packaging and combination links. These standards will cover sanitary conditions in the packaging process, quality control in the assembly process, and inspection procedures for the final product to ensure the safety of the product during the packaging and combining process.

4. Stipulate the compliance of customized health functional food managers: The revised content also clarifies the compliance of customized health functional food managers in management activities. These include, but are not limited to, the standardization of management processes, the integrity of record keeping, and the effectiveness of risk management to ensure the standardization and effectiveness of management activities.

5. New training requirements for customized health functional food sellers: In order to ensure that sales personnel have professional knowledge and skills, the revised content has added training requirements for customized health functional food sellers. These requirements will cover product knowledge training, sales skills training, and customer service training, etc., to ensure that sales personnel can provide consumers with accurate product information and professional consulting services.

In addition, the MFDS issued Notice No. 2024-472, which proposes to amend part of the Law Enforcement Order on Health Functional Foods. These changes mainly include:

1. The business scope of the sales industry of customized health functional food is defined as the sales of customized health functional food: the revised content clarifies the business scope of the sales industry of customized health functional food, including the sales of customized health functional food and the entrusted packaging and combination of health functional food. This provision helps to clarify the business scope of the sales industry and avoid legal disputes caused by unclear business definition.

2. Stipulate the types and limits of liability insurance that can be joined by operators of the customized health functional food sales industry: The revised content stipulates the types and limits of liability insurance that can be joined by operators of the customized health functional food sales industry. This provision aims to further protect the rights and interests of consumers through the liability insurance mechanism and reduce economic losses caused by product quality problems.

3. Specify the qualification standards of customized health functional food managers: The revised content clarifies the qualification standards of customized health functional food managers. These standards will cover the manager's expertise, management experience, and relevant credentials to ensure that the manager has sufficient expertise to manage the production and marketing of customized health functional foods.

The above amendments are open for comment until November 25, 2024. Through these revisions, the Ministry of Food and Drug Safety (MFDS) aims to further regulate the health functional food market, improve product quality and safety levels, protect consumers' rights and interests, and provide clear operational and management guidance for related enterprises. These measures will help promote the healthy development of the healthy functional food industry and provide consumers with safer and more reliable products.