On March 28, 2025, Japan's Consumer Affairs Agency (CAA) announced a comprehensive revision to the Food Labeling Standards, covering food additive labeling, nutrition labeling, and regulations for Foods with Function Claims (FFC). Key updates are summarized below, with amendments indicated in red.
Key Revisions:
1. Removal of Labeling Exemption for Nutritional Fortification Additives
Effective date: March 28, 2025
Grace period until: March 31, 2030
Previously, food additives used for nutritional fortification were exempt from mandatory labeling on processed food products. This exemption has now been removed.
Before | After |
Mandatory Labeling Items for Processed Foods | Mandatory Labeling Items for Processed Foods |
2. Revision of Nutrient Labeling Requirements
Effective date: March 28, 2025
Grace period for (1): until March 31, 2028
This revision updates the reference values for relevant nutrients and refines the labeling specifications in accordance with the 2025 Japanese Dietary Intake Standards.
(1) Updating reference values for labeling nutrients such as protein, calcium, zinc, and sodium.
These values serve as the recommended nutrient intake levels for food labeling, and are calculated using the average nutrient intake for different age and gender groups in Japan, aiming to support public health.
No. | Nutrients & Energy | Unit | Nutrient Labeling Values | |
Before | After | |||
1 | Protein | g | 81 | 85 |
2 | Fat | g | 62 | 70 |
3 | Saturated Fatty Acids | g | 16 | 17 |
4 | n-3 Fatty Acids | g | 2.0 | 2.0 |
5 | n-6 Fatty Acids | g | 9.0 | 10.0 |
6 | Carbohydrates | g | 320 | 320 |
7 | Dietary Fiber | g | 19 | 20 |
8 | Zinc | mg | 8.8 | 8.5 |
9 | Potassium | mg | 2,800 | 2,800 |
10 | Calcium | mg | 680 | 700 |
11 | Chromium | µg | 10 | 10 |
12 | Selenium | µg | 28 | 28 |
13 | Iron | mg | 6.8 | 6.5 |
14 | Copper | mg | 0.9 | 0.8 |
15 | Sodium | mg | 2,900 | 2,700 (however, when converted into salt equivalent, it is 7.0 grams) |
16 | Magnesium | mg | 320 | 320 |
17 | Manganese | mg | 3.8 | 3.2 |
18 | Molybdenum | µg | 25 | 25 |
19 | Iodine | µg | 130 | 140 |
20 | Phosphorus | mg | 900 | 900 |
21 | Niacin | mg | 13 | 13 |
22 | Pantothenic acid | mg | 4.8 | 5.5 |
23 | Biotin | µg | 50 | 50 |
24 | Vitamin A | µg | 770 | 770 |
25 | Vitamin B1 | mg | 1.2 | 1.0 |
26 | Vitamin B2 | mg | 1.4 | 1.4 |
27 | Vitamin B6 | mg | 1.3 | 1.3 |
28 | Vitamin B12 | µg | 2.4 | 4.0 |
29 | Vitamin C | mg | 100 | 100 |
30 | Vitamin D | µg | 5.5 | 9.0 |
31 | Vitamin E | mg | 6.3 | 6.5 |
32 | Vitamin K | µg | 150 | 150 |
33 | Folic acid | µg | 240 | 240 |
34 | Energy | kcal | 2,200 | 2,200 |
(2) Revising reference values for nutrient content claims
The reference value for nutrient content claims such as "contains," "high in," and "fortified" have been updated in Annex 12 to align with current nutritional guidance.
No. | Nutrients | Unit | "Contains" Claim (Per 100g) | "High in" Claim (Per 100g) | "Fortified" Claim (Per 100g) | |||
Before | After | Before | After | Before | After | |||
1 | Protein | g | 8.1 | 8.5 | 16.2 | 17.0 | 8.1 | 8.5 |
2 | Dietary Fiber | g | 3 | 3 | 6 | 6 | 3 | 3 |
3 | Zinc | mg | 1.32 | 1.28 | 2.64 | 2.55 | 0.88 | 0.85 |
4 | Potassium | mg | 420 | 420 | 840 | 840 | 280 | 280 |
5 | Calcium | mg | 102 | 105 | 204 | 210 | 68 | 70 |
6 | Iron | mg | 1.02 | 0.98 | 2.04 | 1.95 | 0.68 | 0.65 |
7 | Copper | mg | 0.14 | 0.12 | 0.27 | 0.24 | 0.09 | 0.08 |
8 | Magnesium | mg | 48 | 48 | 96 | 96 | 32 | 32 |
9 | Niacin | mg | 1.95 | 1.95 | 3.9 | 3.9 | 1.3 | 1.3 |
10 | Pantothenic acid | mg | 0.72 | 0.83 | 1.44 | 1.65 | 0.48 | 0.55 |
11 | Biotin | µg | 7.5 | 7.5 | 15 | 15 | 5 | 5 |
12 | Vitamin A | µg | 116 | 116 | 231 | 231 | 77 | 77 |
13 | Vitamin B1 | mg | 0.18 | 0.15 | 0.36 | 0.30 | 0.12 | 0.10 |
14 | Vitamin B2 | mg | 0.21 | 0.21 | 0.42 | 0.42 | 0.14 | 0.14 |
15 | Vitamin B6 | mg | 0.20 | 0.20 | 0.39 | 0.39 | 0.13 | 0.13 |
16 | Vitamin B12 | µg | 0.36 | 0.60 | 0.72 | 1.20 | 0.24 | 0.40 |
17 | Vitamin C | mg | 15 | 15 | 30 | 30 | 10 | 10 |
18 | Vitamin D | µg | 0.83 | 1.35 | 1.65 | 2.70 | 0.55 | 0.90 |
19 | Vitamin E | mg | 0.95 | 0.98 | 1.89 | 1.95 | 0.63 | 0.65 |
20 | Vitamin K | µg | 22.5 | 22.5 | 45 | 45 | 15 | 15 |
21 | Folic acid | µg | 36 | 36 | 72 | 72 | 24 | 24 |
(3) Revising tolerance ranges and zero thresholds for dietary fiber
The allowable tolerance range for dietary fiber labeling has been revised. In addition, new threshold values for indicating "zero" dietary fiber have been established.
Nutrients & Energy | Unit | Measurement and Calculation Method | Tolerance Range | Thresholds for "Zero" | |
Dietary fiber | g | Prosky's method or high-performance liquid chromatography (HPLC) | Before | ±20% | |
After | ±20% However, if the amount of dietary fiber per 100g of the food (or per 100ml for soft drinks and similar beverages) is less than 2.5g, a tolerance of ±0.5g is permitted. | 0.5g | |||
(4) Introducing methods for the measurement and calculation of vitamin B group.
New standardized methods for measuring and calculating vitamin B group content have been added to support accurate nutrient labeling.
Nutrients & Energy | Unit | Measurement and Calculation Method | Tolerance Range | Thresholds for "zero" | |
Pantothenic acid | mg | Before | Microbiological determination | +80%, ー20% | / |
After | Microbiological determination or HPLC | ||||
Vitamin B6 | µg | Before | Microbiological determination | +80%, ー20% | / |
After | Microbiological determination or HPLC | ||||
Vitamin B12 | µg | Before | Microbiological determination | +80%, ー20% | / |
After | Microbiological determination or HPLC | ||||
3. Revision of Relevant Provisions for Foods with Function Claims (FFC)
Effective date: April 1, 2025
The CAA has consolidated and standardized the provisions in the Food Labeling Standards regarding Foods with Function Claims (FFC), clarifying the procedures for notification, compliance requirements, and reporting methods.
Enterprises submitting FFC notifications must confirm that the product is neither a pharmaceutical nor or a food with safety concerns before submission. Notifications must be submitted electronically via the FFC Notification Database (機能性表示食品制度届出データベース) maintained by the CAA.
The submitted information must comply with the requirements specified in Annex 26 (Items 1 - 6) of the Food Labeling Standards and follow the prescribed format outlined in the new notification. In cases where electronic submission is not possible due to unavoidable circumstances (e.g., natural disasters), submission using the designated paper-based format or an equivalent format will be accepted.
Appended From | Contents |
Appended Form (Ⅰ) | Checklist for preparing notification documents for FFC |
Appended Form (Ⅱ) | Safety evaluation sheet |
Appended Form (Ⅲ) ‐1 -1 | Information on manufacturing and quality control (tablets, capsules, etc., using naturally extracted materials as raw ingredients) |
Appended Form (Ⅲ)-1-2 | Information on manufacturing and quality control (other processed foods) |
Appended Form (Ⅲ)‐2 | Information on production, harvesting, fishing, and quality control (fresh foods) |
Appended Form (Ⅲ)‐3 | Information on the analysis of raw materials and final products |
Appended Form (Ⅲ)‐4 | Information on the analysis of final products using extracts or similar components as functional ingredients
Information on the analysis of raw materials using extracts or similar components as functional ingredients
Evaluation of the equivalence of extracts, etc. in the evaluation of safety and functionality |
Appended Form (Ⅴ)-1-1 | Checklist for the scientific basis of functionality |
Appended Form (Ⅴ)-1-2 | Submitter's involvement in the explanatory materials regarding the functionality to be claimed (systematic review). |
Appended Form (Ⅴ)-2 | Documentation explaining rational reasons for using a human testing method different from the one for Foods for Specified Health Uses (FOSHU) |
Appended Form (Ⅴ)-3 | Supplementary documentation regarding the scientific evidence of the functionality to be claimed |
Appended Form (Ⅴ)-4 | Documents explaining the functionality of functional ingredients (systematic review) |
Appended Form (Ⅴ)-5 | Database search results |
Appended Form (Ⅴ)-6 | Literature search flowchart |
Appended Form (Ⅴ)-7 | List of adopted references |
Appended Form (Ⅴ)-8 | List of excluded references |
Appended Form (Ⅴ)-9 | List of unreported studies |
Appended Form (Ⅴ)-10 | Reference list |
Appended Form (Ⅴ)-11a or b | Quality evaluation sheets for individual studies (human trials) |
Appended Form (Ⅴ)-12 a or b | Quality evaluation sheets for individual studies (observational studies) |
Appended Form (Ⅴ)-13 a or b | Quality evaluation sheet for overall evidence |
Appended Form (Ⅴ)-14 | Summary sheet (qualitative systematic review) |
Appended Form (Ⅴ)-15 | Summary sheet (meta-analysis) |
Appended Form (Ⅴ)-16 | Evaluation sheet for the results of the systematic review |
Appended Form (Ⅴ)-17 | Evaluation sheet for the relevance between systematic review results and the functionality to be claimed |
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