Guidelines for Preparing Documents Requesting the Designation and Revision of Standards for Use of Food Additives

This Guideline applies to food additives and stipulates the items and contents to be included to efficiently prepare request documents for applying new additives.

Contents:

1. Introduction

2. Application Documents

3. Overview Document
   3.1 Attached Documents
   3.2 Application Contents
   3.3 Overview of the Requested Substance
   3.3.1 Name, etc.
   3.3.2 Intended Use and Usage Method
   3.3.3 Structural Formula and Molecular Formula
   3.3.4 Molecular Weight
   3.3.5 Source Organism
   3.3.6 Composition
   3.3.7 Manufacturing Method
   3.3.8 Origin or Discovery Background
   3.3.9 Domestic and International Usage Status
   3.4 Substance Specifications
   3.4.1 Proposed Substance Specifications
   3.4.2 Name
   3.4.3 English Name and Synonyms
   3.4.4 Japanese Synonyms
   3.4.5 Structural Formula
   3.4.6 Molecular Formula or Empirical Formula
   3.4.7 Molecular Weight or Formula Weight
   3.4.8 Chemical Name
   3.4.9 CAS Registry Number
   3.4.10 Definition
   3.4.11 Content
   3.4.12 Enzyme Activity
   3.4.13 Properties
   3.4.14 Identification Test
   3.4.15 Characteristic Values
   3.4.16 Purity Test
   3.4.17 Loss on Drying, Ignition Loss, or Moisture Content
   3.4.18 Residue on Ignition, Ash Content, or Acid-Insoluble Ash
   3.4.19 Microbial Limits
   3.4.20 Assay Method
   3.4.21 Enzyme Activity Measurement Method
   3.4.22 Storage Standards
   3.5 Comparison Table of Proposed and Existing Specifications
   3.6 Basis for Establishing the Proposed Substance Specifications
   3.7 Validation, Verification, and Test Results of Test Methods
   3.8 Analytical Methods for Food Additives in Food
   3.9 Stability
   3.10 Stability in Food
   3.11 Efficacy Data
   3.11.1 Effectiveness as a Food Additive and Comparison with Similar Additives
   3.11.2 Impact on Major Nutrients in Food
   3.12 Safety Data
   3.12.1 Description of ADME, Toxicity Tests, and Human Studies
   3.12.2 ADME Studies
   3.12.3 Toxicity Studies
   3.12.3.1 Genotoxicity Studies
   3.12.3.2 Repeated Dose Toxicity Studies
   3.12.3.3 Carcinogenicity Studies
   3.12.3.4 Reproductive Toxicity Studies
   3.12.3.5 Developmental Toxicity Studies
   3.12.3.6 Allergenicity Studies
   3.12.3.7 Others
   3.12.4 Human Studies
   3.12.5 Safety Evaluations by Japanese and International Organizations
   3.13 Estimation of Daily Intake, etc.
   3.13.1 Estimation of Daily Intake
   3.13.2 Acceptable Daily Intake (ADI), etc.
   3.14 Proposed Use Standards
   3.14.1 Proposed Use Standards or Use Standard Revisions
   3.14.2 Basis for Establishing the Proposed Use Standards
   3.15 Others