/>iIn 2023, we have seen the Korean government actively advancing its plan to foster the regulatory landscape for alternative protein foods by establishing corresponding standards and regulatory pathways to clear such products, as well as addressing labeling concerns.
Specifically, on May 19, 2023, Korea’s Ministry of Food and Drug Safety (MFDS) announced the revised Implementation Rules of the Food Sanitation Act,[1] making it clear that food ingredients obtained by using new technologies such as cell and microbial culture are subject to the temporary recognition of Standards for Approval of Temporary Standards and Specifications for Foods, etc. (“Temporary Standards”). Through the revision of regulations, Korea has confirmed the regulatory framework for the approval of cell-cultured foods in the country.
Dossier requirements for cell-cultured foods application
On October 30, 2023, Korea took a further step in refining this regulatory framework by proposing an official guidance for the dossier preparation of cell-cultured foods application under the draft amendments of the Temporary Standards, and notified the World Trade Organization (WTO)[2]. The draft provides a check-list for the application of temporary recognition for cell-cultured foods, such as domestic and international recognition and usage status data (e.g., domestic/international approval status), data on the origin of the cell, the manufacturing process, the characteristics of raw materials (e.g., appearance, contaminants), as well as safety data (e.g., human body effect data, allergenicity data, toxicity test data).
The dossier requirements for cell-culture foods are quite comprehensive, requiring a wide range of information to ensure a thorough safety assessment. On the other hand, the extensive information and documentation requirements outlined by the government may raise concerns among companies in the alternative protein industry. For instance, the extensive data collection and analysis process, along with the time required for regulatory review, may lead to prolonged approval timelines. To address these concerns, it would be necessary for the food agency to provide support mechanisms, such as pre-consultation, training programs, etc., to address practical challenges faced by businesses. There is no doubt that the draft, once finalized, will serve as a legal basis for the alternative protein industry, as it ensures that industry participants have a clear roadmap for navigating the regulatory landscape to clear their products in the Korean market. All comments on the draft amendments should be submitted to WTO by December 29, 2023.
General standard for products labeled and sold as “alternative protein foods”
Another significant stride of Korea’s MFDS into the alternative protein industry is marked by the release of MFDS Notification No. 2023-56 on August 31, 2023[3]. The notification established a standard for products labeled and sold as “alternative protein foods” under the Korean Food Code, which will become effective on January 1, 2024. Within this regulatory framework, Korea proposes a definition of alternative protein foods and sets forth basic requirements in areas such as technical specifications and manufacturing standards of certain types of alternative proteins. Specifically, “Foods labeled and sold as alternative protein foods,” under the standard, refer to foods that use vegetable ingredients, microorganisms, edible insects, cell cultures, etc., as main ingredients instead of animal ingredients and are “manufactured to have a similar shape, taste, texture, etc.” to existing foods.
The standard establishes manufacturing standards for different types of alternative protein foods, such as fish substitutes and fermented milk alternatives, and provides technical specifications for certain alternative protein foods, e.g., limits on bacterial count and coliforms for sterilized products. Notably, cell-cultured foods may fall within the broad definition of “foods labeled and sold as alternative protein foods”; however, we are unaware of any specific requirements for cell-cultured foods under the standard. Our previous discussion of the draft version of the standard can be found in our newsletter - The South Korean Food Authority Releases New Rules and Policies Supporting the Development of the Alternative Protein Industry.
Labeling guidance for alternative foods
In the meantime, MFDS is actively developing food labeling guidance to facilitate the introduction of alternative protein foods into the Korean market. On November 27, 2023, MFDS published guidelines for the labeling of alternative foods,[4] which applies to businesses engaged in the manufacturing, processing, importing, and distribution of alternative foods, including foods that are manufactured and sold by indicating the use of plant-based ingredients, edible insects, cell-cultured materials, etc., as primary ingredients instead of animal-derived ingredients.
To avoid confusion, the document prohibits the use of primary animal product names such as “beef,” “pork,” “milk,” or “egg” in alternative food product names; however, it allows the use of names associated with animal-based foods, e.g., bulgogi or hamburger steak. For example, it is permitted to use a name that emphasizes the product nature (e.g., plant-based bulgogi) or the name of the substituted raw material (e.g., bulgogi made from soybeans). Notably, the emphasis of the current version is on plant-based alternatives. Per the Q&A session of the document, detailed specifications for cell-cultured foods will be determined through further consultation, especially during the commercialization process in the future.
With the promulgation of new rules and policies, Korea emerges as a promising market for the alternative protein industry to factor into its global expansion strategies, offering opportunities for companies to navigate regulatory requirements and establish a strong presence in a country that is increasingly embracing innovative and sustainable food options.
[2] https://eping.wto.org/en/Search/Index?countryIds=C410&viewData=G%2FSPS%2FN%2FKOR%2F789; https://eping.wto.org/en/Search/Index?countryIds=C410&viewData=G%2FTBT%2FN%2FKOR%2F1178
