Compliance Path for D-allulose Export to Japan and South Korea

D-allulose, as a novel and ideal sugar substitute product, has excellent market application potential in the food industry and is a hot topic of attention both domestically and internationally. China first approved D-allulose as a new food ingredient in 2025. However, the application requirements for D-allulose in Japan and South Korea differ from those in China. In Japan and South Korea, it only needs to complete the enzyme preparation application to be marketed, without requiring a marketing authorization.

CIRS Group will provide you with a detailed overview of the regulatory compliance requirements and current approval status of D-allulose in Japan and South Korea.

Compliance requirements for D-Psicose in Japan and South Korea

Japan: Only requires application for enzyme preparations used in production

Japan’s requirements for D-allulose primarily specify the use of D-allulose-3-epimerase. This means that enzyme preparations for producing D-Psicosee only need to complete the application process for food additives, while the final product D-Psicose does not require registration declaration.

South Korea: Only requires application for enzyme preparations used in production

South Korea’s regulatory requirements for D-allulose are similar to those in Japan, requiring only the enzyme preparation of D-allulose to complete the declaration as a food additive.

It should be noted that on September 17,2025, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a revised manufacturing standard for allulose (Announcement No.2025-403). The new regulations require that starting from October 1, 2026, only allulose products produced using enzyme preparations certified by MFDS may be imported and used. Prior to this date, the market was free to import overseas products that had obtained FDA GRAS notification, with no restrictions on enzyme usage. Therefore, for D-allulose exports to South Korea, it is imperative to promptly apply for enzyme preparation approval.

Approval Status of D-allulose-3-epimerase in Japan and South Korea

Japan–An enzyme preparation passes FSCJ evaluation

Currently, only one enzyme preparation in Japan has passed the safety evaluation by the FSCJ. The details are as follows:

Evaluation number	kya18101111102
Evaluate entries	Allulose isomerase produced using the Escherichia coli K-12W3110 (pWKLP) strain
Evaluation department	Food Safety Commission (FSCJ)
Appliant	Matsugaya Chemical Industry Co., Ltd.
Product characteristics	A brownish to dark brown liquid or gray powder
Scope of Use	Food additive, used as a manufacturing agent for allulose production
Reception time	2018.10.11
Evaluation result notification time	2019.3.26
Assessment result	Regarding the production of allulose isomerase using the Escherichia coli K-12W3110 (pWKLP) strain, an evaluation was conducted based on safety assessment criteria for biomanufactured additives, concluding that it poses no risk to human health. Additionally, when used correctly as an additive, this enzyme preparation presents no safety concerns and does not require a daily intake limit.

The evaluation results were announced on the website of Japan's Consumer Affairs Agency on March 31,2020, indicating compliance for use.

South Korea – One company's two enzyme preparations receive approval

According to information retrieved from the official website of the Korea Food Safety Agency, the latest provisional list of approved food additives was released on February 6, 2026. The list indicates that currently only one enterprise's D-allulose-3-epimerase has been approved. Details are as follows:

product name

Application enterprise

Accept content

Recognition date

D-allulose-3-epimerase

Liquid: Matsurase FE

Powder form: Matsurase FD

한국마쯔다니

Co., Ltd. (Korea Songgu)

Definition: This isomerase is produced using the transgenic microorganism Escherichia coli K-12 as the production strain. The enzyme can isomerize D-fructose to generate D-allulose.

Quality specifications: characteristics, identification tests, purity tests (arsenic, lead, coliform group, Salmonella, Escherichia coli), activity test methods

Indications: Enzyme preparations

Use in accordance with the general usage criteria specified in II.2.1)

2023.10.24

Requirements for Food Additive Declaration Documents in Japan and South Korea

Korea

The declaration of food additives in South Korea is regulated by the MFDS). The required submission documents are as follows:

Data Requirements	Explaination
Product information	Name, source, production process information, etc.
Specification of ingredients and testing methods	Quality specifications and testing methods
Safety data	90-day repeated dose toxicity, genotoxicity, and immunotoxicity (allergic) tests
Intake assessment data	Instructions for use, basic intake studies, EDI and ADI assessments, etc.
Description of usage abroad	Examples of approved cases from overseas, other safety documentation, etc.
Korean translation	/

Japan

The declaration of food additives in Japan is initiated by the applicant submitting an application to the Ministry of Health, Labour and Welfare (MHLW), followed by risk assessment conducted by the FSCJ. The assessment results are reviewed by the MHLW before final approval and official announcement. The required documentation for food additive declaration in Japan includes the following:

Data Requirements	Explaination
Product information	Name, source, physicochemical properties, production method, usage recommendations, usage in other countries, evaluations by international organizations, and other information used to assess the health impact of the product
Valid data	Similar to domestic technical necessity documentation
Safety data	Absorption and metabolism studies in organisms, toxicology studies, daily intake estimation, and human-related research data
Japanese translation	/

CIRS Services

CIRS Group not only has a professional technical team for the application of new food additive varieties in China, but also maintains a reserve of professional technical talent overseas to meet customers’ market expansion needs in different countries and regions. CIRS has subsidiaries in Tokyo, Japan, and Seoul, South Korea, namely CIRS Japan Co., Ltd. and CIRS Group Korea Co., Ltd. Both subsidiaries possess the corresponding qualifications and can act as applicant representatives to apply for local new food additive varieties in Japan and South Korea. Enterprises are welcome to inquire.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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