We provide prior consultation for applicants who submit application documentation for the designation of food additives and the revision of use standards.　　　　　

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＜Useful Information Resources when you prepare the Summary Report on the proposed Food Additive(s)＞

The overview document is divided into four components (I. General Information on Food Additives, II. Effectiveness Evaluation of proposed food additive, III. Safety Assessment of proposed food additive, IV. List of References). The following is a summary of where to check the relevant information in �T, �U, and �V, as well as other reference links as described in the "Guideline".

For the preparation of I. General Information on Food Additives(Guideline p.1〜13）
● Name, classification, usage of food additives

The Codex Alimentarius Commission

・CLASS NAMES AND THE INTERNATIONAL NUMBERING SYSTEM FOR FOOD ADDITIVES
CXG 36-1989

　　　

Consumer Affairs Agency, Japan

・Food additives

・Standards for use of food addives

　　　　　

●Standard(s) for usages in abroad

The Codex Alimentarius Commission　　　　 　

・GENERAL STANDARD FOR FOOD ADDITIVES　CODEX　STAN 192-1995

・GSFA online

　　　　

EU

・Food Additives Database

　　　　

USA

・21CFR

・GRAS Notice Inventory

　　　　

Australia and New Zealand

・FSANZ

●Safety Assessment of food additives in national and international bodies　　

JECFA

・TRS

・FAS

・INCHEM

　　

EFSA

・EFSA

・Re-evaluation

　　　　 　　　　

SCF

・SCF

　　　　 　　　　

FDA

・SCOGS

・NTIS

・GRAS Notice Inventory

・FDA　Freedom of Information

　　　　　 　　　　

FSANZ

・FSANZ

FSC

・FSC　Risk assessment reports

　　　

●Specification of food additives in compiled resources　　

・ Japan’s Specifications and Standards for Food Additives, 10th Edition (in Japanese)

・Japan’s Specifications and Standards for Food Additives, 9th Edition

・JECFA

・EU

・FCC

・Japanese Pharmacopoeia(JP)

・US Pharmacopeia (USP)

　　　 　　　　

For the preparation of II. Effectiveness Evaluation of proposed food additive（Guideline p.14~15）

・Japanese case (Ministry of Health, Labour and Welfare, Pharmaceutical Affairs and Food Sanitation Council, Subcommittee on Additives, Report on possible new designation)

・Australia and New Zealand case（See to FSANZ Approval Raport)

・EU case（See to EFSA Scientific opinion)

　　　　

For the preparation of III. Safety Assessment of proposed food additive（Guideline p.16~36）
●Disposition, toxicity and other related studies

・FSC　Risk assessment reports

・TOXNET

・PUB MED

●Estimation of Daily Intake of proposed food additive　　

JAPAN

・National Health and Nutrition Survey(Japanese)

・Estimation of daily intake of food additives by a market basket method (Japanese)

・Data of average intake of individual food-additional data to the survey report on food intake and frequency(Japanese)

　

The United States

・FDA Guidance for Industry: Estimating Dietary Intake of Substances in Food

　

Other useful resources
●National Institute of Health Sciences (NIHS, Japan)

NIHS Home Page

・Food safety information (Japanese)

・Chemicals safety information (Japanese)

・Japan Existing Chemical Data Base

・ICSC(Japanese)

　

●National bodies relating activities

・Consumer Affairs Agency

・Food Safety Commission of Japan

・Ministry of Health, Labour and Health

・Ministry of Agriculture, Forestry and Fisheries

　

●Industrial, Scientific association

・Japan Food Additives Association

・The Japan Food Chemical Research Foundation

・Japan Food Hygiene Association (Japanese)

・Japan Flavor & Fragrance Material Associatrion

・International Pharmaceutical Excipients Council Japan

　

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• Note:
  The face-to-face meeting is conducted in Japanese at our center. Non-Japanese-speaking applicants are requested to be accompanied by an interpreter, if necessary.
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