EU, U.S., and Third World Country Regulations and Japanese Legislation - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 320

table 10.2 Documentation required in Japan to apply for the Designation of Food

additives and for the revision of their Standards for Use

Document category Approval Revision

1. Summary

2. Chronology on origin or development and overseas use conditions
(1) Details of origin or development
(2) Overseas use conditions

3. Physiochemical chracteristics and specifications
(1) Name
(2) Structural formula and rational formula
(3) Molecule formula and formula weight
(4) Assay
(5) Methods of manufacturing
(6) Description
(7) Identification tests
(8) Specific properties
(9) Purity tests
(10) Loss on drying, loss on ignition, or water
(11) Residues on ignition
(12) Method of assay
(13) Stability
(14) Analytical method for the food additives in foods
(15) Principles to establish proposed specifications

4. Effectiveness
(1) Effectiveness and comparison in effect with other similar food additives
(2) Stability in foods
(3) Effects on nutrients of foods

5. Safety evaluation
(1) Toxicity studies
1) 28-day toxicity study
2) 90-day toxicity study
3) One-year toxicity study
4) Reproduction study
5) Teratogenicity study
6) Carcinogenicity study
7) Combined chronical toxicity/carcinogenicity study
8) Antigenicity study
9) Mutagenicity study
10) General pharmacological study
(2) Metabolism and pharmacokinetic studies
(3) Daily intake of food additives

6. Proposed sandards for use

Source: Japan Food Chemicals Research Foundation, Japanese Guidelines.
Annex 5: ™e guidelines for designation of food additives, and for revision
of standards for use of food additives (Excerpt), 1-11, 2010. With permission.

Note:
Documents marked with the symbol are basically required.
Documents marked with the symbol should be submitted, only when considered as necessary:
e.g., where new information is obtained.