Voluntary Report - public distribution

**Date:** 12/12/2005

**GAIN Report Number:** JA5074

JA5074

**Japan**

**Sanitary/Phytosanitary/Food Safety**

**Revision of Specification and Standards for Food Additives**

**2005**

**Approved by:**

![](media/image1.wmf)Rachel Nelson

U.S. Embassy

**Prepared by:**

Tetsuo Hamamoto

**Report Highlights:**

Japan invited foreign embassies to comment on revision of the
specification and standards for food additives. The deadline for
submitting these comments is December 22, 2005. This proposal will be
open for comments again when it is submitted to the WTO.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Tokyo \[JA1\]

\[JA\]

On December 8, 2005, the Ministry of Health, Labor, and Welfare (MHLW)
invited foreign Embassies in Tokyo to comment on revision of
specification and standards for food additives. Details on this proposed
action given by MHLW are shown below. Foreign governments have until
December 22, 2005 to comment.

All interested parties are encouraged to send their comments, well
before the deadline, for consideration to USDA's Foreign Agricultural
Service. The office responsible for the comments is:

Food Safety and Technical Services

International Trade Policy Division

USDA Foreign Agricultural Service

Fax: 202-690-0677

Email: <fstsd@fas.usda.gov>

1\. Introduction

Since 1960 when the first edition of the Japanese official compilation
was prepared, the compilation has been updated regularly. The last
edition, which was the seventh edition, was published in 1999. This
newly proposed revision will be carried out to contain specifications
and standards that have been newly established or modified since then.

2\. Purpose

The official compilation of food additives will be revised to:

A. Develop compositional specifications for non-synthetic food additives
by establishing specifications for 61 existing food additives and one
ordinary food used as food additive and containing the established
standards in the official compilation. In the Food Sanitation Law,
"existing food additives" means natural additives that have been
manufactured, distributed, and used before the 1995 amendment of the
Food Sanitation Law. "Ordinary foods used as food additives" means
substances that are generally consumed as food but also used as a food
additive.

B. Contain compositional specifications for food additives which have
been designated by the Minister of Health, Labour and Welfare after the
publication of the seventh edition and use standards revised for food
additives which have already been designated.

C. Reflect advances in science and technology and new knowledge in the
existing general testing methods, standards, and specifications for food
additives, and make them more appropriate in light of the global level
of science.

D. Introduce infrared spectrophotometry in identification tests wherever
possible, to improve test accuracy.

E. Review the existing standards and specifications based on standards
established by the international evaluating organization (Joint FAO/WHO
Expert Committee on Food Additives) for the purpose of international
harmonization.

F. Modify the ways chemical names and structural formulas are described
and the wording to improve convenience of the official compilation.

3\. Outline of the revision

A. Compositional specifications for 63 substances (61 additives) and 1
ordinary food used as food additive will be newly established and
listed.

i\. Substance name

See the next page of this document.

ii\. Definition

The descriptions of sources and producing methods have been according to
the List of Existing Food Additives and the detailed list of existing
food additives, which appear in Attachment 1 to Director-General Notice
No. 56, "Food Additive Labeling under the Food Sanitation Law"
(Department of Food Safety, Pharmaceutical and Food Safety Bureau,
Ministry of Health, Labour and Welfare, May 23, 1997).

Nomenclatures have been added.

iii\. Identification tests

The chemical characteristics of individual substances and the quality
commercial products have been considered.

iv\. Purity tests

Specifications have been established for categories including heavy
metals, lead, arsenic, and microorganism, in light of the quality of
commercial products.

B. The standards and specifications for 20 food additives, which have
been designated after the publication of the seventh edition, will be
contained. The use standards that have were revised after the latest
publication will be contained.

C. General testing methods applied commonly to the substances and
testing method applied to individual substances in the monographs will
be revised to improve the operability and accuracy.

D. Infrared spectrophotometry will be newly introduced in the
identification tests of 36 substances. Reference spectra which appear in
the seventh edition will be reviewed, and the eighth edition will
contain 56 spectra in total.

E. Harmful reagents will be replaced with less harmful ones in order to
improve the safety of examinations. Some tests for taste, which inflict
unnecessary burden on examiners, will be abolished.

F. Compositional specifications, especially purity tests, will be
revised in order to harmonize Japanese standards with international
standards, and to reflect market distribution conditions.

G. Nomenclatures will be added, in order to clarify definitions of
source plants and microorganisms.

H. The IUPAC (International Union of Pure and Applied Chemistry)
nomenclature system will be introduced for substance names. For some
reagents, Japan Industrial Standard Numbers will be added and the
wording and description of structural formulas will be standardized, in
order to improve convenience.

List of 61 Existing food additives (63 substances) and 1 ordinary food
used as food additive

1\. Red Cabbage Color (food ingredient)^1^

2\. N-Acetylglucosamine

3\. 5'-Adenylic Acid

4\. L-Arabinose

5\. Inositol (Myo-Inositol)

6\. Acid Clay

7\. Curdlan

8\. Licorice Extract

9\. Gardenia Blue

10\. Gardenia Red

11\. Gardenia Yellow

12\. α-Glucosyltransferase Treated Stevia

13\. Enzymatically Modified Isoquercitrin

14\. Enzymatically Modified Hesperidin

15\. Enzymatically Decomposed Lecithin

16\. Yeast Cell Wall

17\. Bone Charcoal

18\. Psyllium Seed Gum

19\. Activated Acid Clay

20\. Cyanocobalamin

21\. Cyclodextrin \[α-Cyclodextrin, γ-Cyclodextrin\]

22\. 5'-Cytidylic Acid

23\. Calcinated Calcium \[Calcinated Shell Calcium, Calcinated Eggshell
Calcium\]

24\. Milt Protein

25\. Stevia Extract

26\. Spirulina Color

27\. Crude Magnesium Chloride

28\. Taurine (Extract)

29\. Tamarind Seed Gum

30\. Tara Gum

31\. Thujaplicin (Extract)

32\. Dextran

33\. Tocotrienol

34\. d-γ-Tocopherol

35\. d-δ-Tocopherol

36\. Tomato Color

37\. Bacillus Natto Gum

38\. Naringin

39\. Paraffin Wax

40\. Microfibrillated Cellulose

41\. Fukuronori Extarct

42\. Pullulan

43\. Bataine

44\. Haematococcus Algae Color

45\. Heme Iron

46\. Bentonite

47\. ε-Polylysine

48\. Microcrystalline Wax

49\. Macrophomopsis Gum

50\. Purple Sweet Potato Color

51\. Purple Corn Color

52\. Menaquinone

53\. Chinese Bayberry Extract

54\. Yucca Foam Extract

55\. Rakanka Extract

56\. Lac Color

57\. Lanolin

58\. Rhamsan Gum (Rhamsan Polysaccharides)

59\. Lysozyme

60\. D-Ribose

61\. Enzymatically Decomposed Rutin

62\. Enju Extract

^1^: Ordinary food used as food additive

The revisions of general tests and specifications for individual food
additives are outlined

in Tables 1-3.

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