According to the latest notification, the Japan Ministry of Health, Labour and Welfare (MHLW) released an amendment to the Guidelines for Designation of Food Additives and Revision of Usage Standards, which mainly indicates the application procedure, necessary materials requirements for applying for new additives and modifying designated additives. MHLW removed the antigenicity test method in this notification and amended some other provisions related to required materials for assessment.
Required Materials for Assessment
Japan's food additives are regulated by positive lists. If the product contains a significant additive and there is no suitable alternative, or the amount/object of the additive is different from the official requirements. In that case, enterprises can apply for a new designation or revision of food additives. The following are the required additive information and safety data for assessment.
Previous | Present | Designation | Revision |
/ | 1. Ingredient specifications proposal | Required | / |
/ | 2. Use standard and comparison table | Required | Required |
1. Summary of information | 3. Summary of information | Required | Required |
/ | 4. Name and usage | Required | Required |
2. Origin or process of discovery, and usage in other countries | 5. Origin or process of discovery | Required | As necessary |
6. Usage in other countries | Required | Required | |
/ | 7. Assessments by international organizations and other organizations | Required | As necessary |
3. Physiochemical properties and specification | 8. Physiochemical properties and specification | Required | As necessary |
4. Suggestions for usage standards | 9. Suggestions for usage standards | Required | Required |
5. Effectiveness of materials | 10. Effectiveness of materials | / | / |
(1) Effectiveness as a food additive and comparison of effects with other similar additives; | (1) Effectiveness as a food additive and comparison of effects with other similar additives; | Required | Required |
(2) Stability in food | (2) Stability in food | Required | As necessary |
(3) Effects of major nutritional ingredients in foods | (3) Effects of major nutritional ingredients in foods | Required | As necessary |
6. Safety materials | 11. Safety materials | ||
Notes：
For a new additive, if only the base part is different from the designated food additive, or it is an isomer, or there are other reasonable reasons, the attachment of the materials may be omitted as appropriate. However, when additional toxicity may appear after the proposed food additive is combined with designated additives, all the above materials must be submitted.
It is required to briefly summarize the information from 4 to 11 in Japanese in the "summary of information". However, attached materials other than the summary may be written in English. In addition, when attaching documents written in languages other than Japanese or English, the Japanese translation shall be attached.
Applicants shall attach the latest safety materials in accordance with the Food Health Impact Assessment Guidelines for Additives as follows. The antigenicity study has been removed from the list.
Safety materials | Designation | Revision |
1. Tests for disposition in organisms | Required | As necessary |
2. Toxicity | Required | As necessary |
(1) Genotoxicity studies | Required | As necessary |
(2) Repeated-dose toxicity studies | Required | As necessary |
(3) Carcinogenicity studies | Required | As necessary |
(4) Reproductive toxicity studies | Required | As necessary |
(5) Developmental toxicity studies | Required | As necessary |
(6) Allergenic potential studies | Required | As necessary |
(7) Other studies | As necessary | As necessary |
3. Findings in humans | Required | As necessary |
4. Estimation of daily intake, etc. | Required | Required |
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