Japan's Specifications and Standards (7th-Ed.)

	The Japan Food Chemical Research Foundation
Japan's Specifications and Standards (7th-Ed.)
Last update：2006/11/30

This website is an English translation of the official compilation of food additives, seventh edition. In the case of any discrepancy between the Japanese original and the English translation, the former will take priority.

The Japan Food Chemical Research Foundation

Seventh Edition

Japan's
Specifications and Standards
for
Food Additives

Published by

The Ministry of Health and Welfare

2000

Preface

The Food Sanitation Law requires the Minister of Health and Welfare to prepare an official compilation of food additives to contain specifications and standards. The Ministry published the first Japanese edition in 1960. Since then, it has been updated regularly. The latest edition (seventh) was published in 1999.
The updating of the publication is conducted to provide new information on specifications and standards, and to attain harmonization with international standards, including those of the Food and Agriculture Organization of the United Nations and the World Health Organization.
The Ministry also has worked to prepare English translations (the title changed from The Japanese Standards for Food Additives to Japan's Specifications and Standards for Food Additives) since the first Japanese edition was published. This activity is very important to enable non-Japanese to have access to the Japanese food additives standards.
The role of food additives has become more important in food manufacturing because the importation of processed foods, as well as the domestic production of these, have been increasing continuously in recent years. Under such circumstances, the need for the English edition is becoming stronger.
I hope that this English translation will be helpful in gaining a deeper understanding of Japan's standards for food additives. I also hope that it will contribute to promoting a concerted review of international standards in light of advances in science and technology.
I sincerely acknowledge the efforts of all those who participated in preparing this publication.

September 2000

Itaru Nishimoto
Director-general
Environmental Health Bureau
Ministry of Health and Welfare

Contents

Introduction to the seventh edition
Explanatory notes
Historical background
A. GENERAL NOTICES
B. GENERAL TESTS
C. REAGENTS, SOLUTIONS, AND OTHER REFERENCES MATERIALS
D. MONOGRAPHS
E. STANDARDS FOR MANUFACTURING
F. STANDARDS FOR USE
G. STANDARDS FOR LABELING

Introduction to the Seventh Edition

In March 1994, the Ministry of Health and Welfare established two panels: the Panel on the Preparation of the Official Compilation of Food Additives (seventh edition) and the Panel for the Discussion on Monographs, etc. in the Official Compilation of Food Additives (seventh edition). The purpose of these panels was to prepare the seventh edition in conjunction with the advances in analytical technology and the progress in technologies for manufacturing food additives and controlling their quality.
The panels worked to develop specifications for existing food additives (additives derived from natural sources, or so-called natural additives), based on the revised Food Sanitation Law (revised in 1995), to compile new and improved test methods commensurate with the progress in scientific technology, and to attain international harmonization of standards.
In May 1998, the Minister of Health and Welfare referred a draft of the official compilation of food additives, prepared by the panels, to the Food Sanitation Council. In response to this referral, the Joint Committee on Toxicity and Food Additives, under the Council, thoroughly reviewed the draft, and in March 1999 submitted a final report to the Minister.
The seventh edition of Japan's Specifications and Standards for Food Additives carries General Notices (43 items); General Tests (43 items); Reagents, Solutions, and Other Reference Materials (10 items); Monographs (416 items); Standards for Manufacturing; Standards for Use; and Standards for Labeling.

The following is an outline of the revision:
1. General Notices
(1) Units and Symbols: kilogram-force (kgf), mm of mercury (mmHg), and normality (N)/mol (M) have been replaced by newton (N), pascal (Pa)/kilopascal (kPa), and mole per liter (mol/l)/millimole per liter (mmol/l), respectively.
(2) A definition of "a heated solvent or hot solvent" has been added.
(3) Definitions of "slightly acidic," "weakly acidic," "strongly acidic," "slightly alkaline," "weakly alkaline," and "strongly alkaline" have been added.
(4) A definition of "solubility" has been added.

2. General Tests
(1) The added tests are the Ash and Acid-insoluble Ash Limit Tests, Color Value Test, Inductively Coupled Plasma-Atomic Emission Spectrometry, Microbial Limit Tests, and Specific Rotation Measurement. The Optical Rotation Measurement has been removed.

(2) The amended test are the Arsenic Limit Test, Atomic Absorption Spectrophotometry, Coloring Matter Tests, Coloring Matter Aluminum Lake Tests, Infrared Spectrophotometry, Heavy Metals Limit Test, Lead Limit Test, Specific Gravity Measurement, Viscosity Measurement, and Water Determination.

(3) In Infrared Spectrophotometry, the identification method using a reference spectrum has replaced the method using wave numbers for some additives.

3. Monographs and Storage Standards
(1) The relevant parts have been amended in accordance with the revised General Notices and General Tests.

(2) Chemical names and CAS numbers based on IUPAC have been added.

(3) The following additives have been removed or added, because their designation was withdrawn or they were newly designated as approved after the sixth edition was published:
Removed
Bleaching Powder, Oxyethylene Higher Aliphatic Alcohols, and Polyoxyethylene Higher Aliphatic Alcohols.
Added
Acesulfame Potassium (effective as of April 25, 2000; appearing only in the English version) Imazalil, Polyvinylpolypyrrolidone, Potassium Gluconate, Sodium Gluconate, Sucralose (effective as of July 30, 1999; appearing only in the English version), and Xylitol.

(4) Major revisions have been made for the following additives:
Ester gum, Coloring Matters and Coloring Matter Aluminum Lakes, Polyvinyl Acetate, and Vitamin A Esters of Fatty Acids.

(5) Specifications for some existing food additives have been established.
A. Target chemicals (60 chemicals, 3 preparations).
Amino Acids (13 chemicals, 3 preparations)
L-Alanine, L-Alanine Solution, L-Arginine, L-Asparagine, L-Aspartic Acid, L-Cystine, L-Glutamine, L-Histidine, L-Hydroxyproline, L-Leucine, L-Lysine, L-Lysine Solution, L-Proline, L-Proline Solution, L-Serine, and L-Tyrosine.

Food Colors (18 chemicals)
Beet Red, Black Currant Color, CaramelI, CaramelII, CaramelIII, CaramelIV, Carrot Carotene, Carthamus Red, Carthamus Yellow, Chlorophyll, Cochineal Extract, Dunaliella Carotene, Grape Skin Extract, Marigold Color, Monascus Color, Palm Oil Carotene, Paprika Color, and Turmeric Oleoresin.

Thickeners and Stabilizers (13 chemicals)
Alginic Acid, Carob Bean Gum, Dammar Resin, Gelan Gum, Guar Gum, Gum Arabic, Gum Ghatti, Karaya Gum, Pectin, Purified Carrageenan, Semirefined Carrageenen, Tragacanth Gum, and Xanthan Gum.

Emulsifiers (one chemical)
Quillaia Extract.

Antioxidants (two chemicals)
Mixed Tocopherols and d-Tocopherol.

Sweeteners (one chemical)
Thaumatin.

Chewing Gum Bases (4 chemcials)
Bees Wax, Candelilla Wax, Carnauba Wax, and Shellac.

Enzymes (4 chemicals)
Bromelain, Papain, Pepsin, and Trypsin.

Processing Agents (4 chemicals)
b-Cyclodextrin, Microcrystalline Cellulose, Powdered Cellulose, and Vegetable Tannin

B. Definitions
a. The descriptions of sources and the methods of manufacturing of additives have been based on the List of Existing Food Additives (the Ministry of Health and Welfare Announcement, No. 102, April 1996).

b. Because lactose, dextrin, and fats/oils are normally added to some commercial food additives (such as Chlorophyll and Turmeric Oleoresin) for stabilizing and standardizing, a statement to the effect that the additive usually contains these substances has been added to the definitions.

C. Color Value
Color value has been established as a measure for identifying the content of an additive because natural coloring agents include various minor ingredients, besides the major ingredients.
The Color Value Test is intended to determine the absorbance at the wavelength of maximum absorption in the visible range for a solution of the food color.

D. Impurities
Specifications for impurities including arsenic, lead, heavy metals, and microorganisms have been established.

4. Standards for manufacturing
Standards for usable solvents, including the description of substance names and maximum residue limits, have been established for some additives such as spice extracts.

5. Standards for labeling
A standard for the labeled content (value) has been added.

Explanatory Notes

General Notices This section gives general rules for performing tests in accordance with specifications and standards.

General Tests This section describes practical test methods common to certain additives.

Reagents, Solutions, and Other Reference Materials This section contains specifications concerning reagents, test solutions, and standards solutions in alphabetical order.

Monographs This section consists of "Definition," "Content," " Description," "Identification," "Purity," " Water Content," "Loss on Drying," "Residue on Ignition," "Assay," and "Storage Standards."

Standards for Manufacturing This section describes general and specific standards concerning the manufacture of food additives.

Standards for Use This section gives target foods, maximum use levels in each target food, and other restrictions for each of the additives with standards for use.

Standards for Labeling This section specifies items to be declared for additives and relevant requirements.

Background

In Japan, the first nationwide management of food safety was initiated with a notification of "the Ministerial Ordinance on Food Coloring with Aniline and Other Mineral Pigments (Law No. 35)," which was issued from the Minister of Home Affairs to local governments on April 18, 1878.
However, it is not until February 24, 1900 that the general law concerning food sanitation was enacted (Law No. 15, the Law for the Control of Foods and Things Relating to Foods). Based on the law, the Minister of Home Affairs established enforcement regulations. These regulations were prescribed concerning specific matters, including those given below. They were promulgated under the approval of the Central Food Sanitation Council.

1) Enforcement Regulations for the Control of Poisonous Coloring Matters
(Ministry of Home Affairs Ordinance No. 17, April 17, 1900)
2) Enforcement Regulations for the Control of Artificial Sweetening Agents
(Ministry of Home Affairs Ordinance No. 31, October 16, 1901)
3) Enforcement Regulations for the Control of Food Preservatives
(Ministry of Home Affairs Ordinance No. 10, August 28, 1903)
4) Enforcement Regulations for the Control of Methyl Alcohol
(Ministry of Home Affairs Ordinance No. 8, May 28, 1912)

On June 15, 1928, regulations for bleaching agents were newly added to the Enforcement Regulations for the Control of Food Preservatives. Then, these regulations were replaced by the Enforcement Regulations for the Control of Food Preservatives and Bleaching Agents (published on June 15, 1928, Ministry of Home Affairs Ordinance No.22). Basic laws concerning food sanitation had been developed by the early Showa era (early 1930s).
On December 24, 1947, the Food Sanitation Law was enacted as a comprehensive law concerning food sanitation (Law No. 233), based on the enforcement of the new constitution enacted after World WarⅡ. After half a year, both the "Enforcement Regulations of the Food Sanitation Law" (Ministry of Health and Welfare Ordinance No. 23, July 13, 1948) and the "Specifications and Standards for Foods, Food Additives, Apparatus, and Containers/Packages under the Provisions of Articles 7 and 10" (Ministry of Health and Welfare Notification No.54, July 13, 1948) were established under the Food Sanitation Law.
In June 1957, the Food Sanitation Law was partially revised. A new provision (Article 13) concerning an official compilation of food additives was added. That revision was triggered by food poisoning which was caused in 1955 by formulated dried milk contaminated with arsenic. That poisoning case resulted in a high infant death-toll.
During the same revision, a matter was added to Article 25 Paragraph 1. The paragraph has since specified a matter about the preparation of the official compilation of food additives as one of those to be discussed by the Food Sanitation Council.
Article 13. The Minister of Health and Welfare shall prepare the official compilation of food additives in order to collect therein the specifications and standards for the additives for which specifications and standards have been established pursuant to the provisions of Article 7, paragraph 1 and to collect therein the standards for the additives for which standards have been established pursuant to the provisions of Article 11, paragraph 1.
Article 25, paragraph 1. The Food Sanitation Council shall be established under the supervision of the Minister of Health and Welfare to investigate and deliberate matters relating to the prevention of food poisoning, matters relating to the preparation of the official compilation of food additives, and other important matters relating to food sanitation in response to a request for consultation by the Minister of Health and Welfare.

Under the above provisions, the Food Sanitation Council established a subcommittee on the official compilation of food additives, in response to a request by the Minister of Health and Welfare. After discussing a draft of the compilation, the subcommittee submitted the final report to the Minister of Health and Welfare on November 12, 1959.
Based on the report, the Minister published on March 15, 1960 the first Japanese edition of the official compilation of food additives. That edition carried standards and specifications for 198 additives. The second edition was published in 1966, the third in 1974, the fourth in 1978, the fifth in 1986, and the sixth in 1992.