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On March 24, 2025, Japan's Consumer Affairs Agency (CAA) released a revision to the Guidelines for Preparing Documents Requesting the Designation and Revision of Standards for Use of Food Additives, which aims to enhance international harmonization in food additive approval procedures. While the fundamental application process remains unchanged, the update refines document preparation requirements and provides clearer instructions for applicants.
Key updates:
Compared to the previous version, the 2025 revision introduces a more structured and detailed format for application requirements. The key updates are as follows:
1. Expanded and Reorganized Structure
The 2025 revision introduces a more detailed hierarchical structure, breaking down broader chapters to clarify requirements. For example, the previous edition included only general guidelines on safety. In contrast, the 2025 edition subdivides safety evaluations into ADME (Absorption, Distribution, Metabolism, Excretion) studies and toxicity assessments, including genotoxicity, repeated-dose toxicity, carcinogenicity, reproductive toxicity, developmental toxicity, and allergenicity.
2. Detailed Additive Properties
The revised guidelines introduce more explicit criteria for chemical and physical properties, such as:
CAS number: If available, CAS registration numbers, INS (International Numbering System) numbers, or EU food additive numbers should be provided.
Enzyme additives: The revised guidelines introduce specific requirements for enzyme additives, including methods for determining enzyme activity, to clarify the testing criteria.
Molecular and structural information: For instance, if an additive consists of a mixture of isomers, and the total content of these isomers reaches 90.0% or more, the structural formula of each isomer must be provided, even if the content of each individual isomer is below 90.0%.
3. Refined Requirements for Additive Use and Effectiveness
The revised guidelines introduce more rigorous efficacy testing requirements, focusing on detailed experimental design and data analysis. Key points include:
A requirement to provide both theoretical explanations and specific test results to support efficacy claims.
The necessity of well-designed experiments, including dose-response studies and statistical validation.
A mandate to report all test results, even if the new additive does not surpass existing alternatives.
Before | After |
For efficacy testing, tests should be conducted to verify that the food additive achieves the expected effect for its intended use. For example, in the case of antioxidants, tests should demonstrate the antioxidative effect on the target food, considering the relationship between the amount added and the passage of time. Similarly, for preservatives, tests should confirm the effectiveness of the additive in extending the shelf life of the target food. If there are already approved food additives with the same intended use, it is preferable to compare their effectiveness with that of the proposed additive. | 3.11.1 Efficacy as a Food Additive and Comparison with Similar Additives
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Clearer instructions
At the end of the guidelines, a table is provided outlining the required documents for each section. This summary helps enterprises prepare the mandatory documents according to the type of food additive being applied for. Here is an example:
Guidelines | Additives | Enzymes | Nutritional ingredients | Flavors | ||||||||
Ⅰ | Ⅱ | Ⅲ | Ⅰ | Ⅱ | Ⅲ | Ⅰ | Ⅱ | Ⅲ | Ⅰ | Ⅱ | ||
2.1 | Applications must include an application form and supporting documents. | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
2.1.1 | Requests for the new designation of a food additive must be submitted using the application form in Annex 1. | Yes | Yes | No | Yes | Yes | No | Yes | Yes | No | Yes | Yes |
2.1.2 | When applying for the designation of a food additive, a proposed specification for the additive must be included as a supporting document. | Yes | Yes | No | Yes | Yes | No | Yes | Yes | No | Yes | Yes |
2.1.3 | If it is necessary to specify the target food products, usage levels, or methods of use for the requested additive, a proposed usage standard must be included as a supporting document. | Yes | Yes | No | Yes | Yes | No | Yes | Yes | No | Yes | Yes |
2.1.4 | Requests for amendments to existing standards for food additives must be submitted using the application form in Annex 2. | No | No | Yes | No | No | Yes | No | No | Yes | No | No |
2.1.5 | For requests to revise usage standards, a proposed usage standard and a comparison table showing the changes before and after the revision must be included as supporting documents. | No | No | Yes | No | No | Yes | No | No | Yes | No | No |
2.1.6 | For requests to revise specifications, a proposed specification for the additive must be included as a supporting document. | No | No | Yes | No | No | Yes | No | No | Yes | No | No |
Notes:
Ⅰ refers to New Designation (新規指定), which is the initial approval of a new food additive that has not been previously authorized.
Ⅱ refers to Specification Revision (規格改正), which involves modifications to the specifications of an already approved food additive, such as adjustments to purity requirements, content limits, or testing methods.
Ⅲ refers to Usage Standard Revision (基準改正), which includes changes in the application scope, maximum usage level, or conditions of use for an already approved food additive.
The terms enzymes, nutritional ingredients and Flavors refer to different categories of food additives as classified by the Food Safety Commission of Japan (FSC). Each category follows a specific set of guidelines for health impact assessments.
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