Voluntary Report - public distribution

**Date:** 7/8/2004

**GAIN Report Number:** JA4062

JA4062

**Japan**

**Sanitary/Phytosanitary/Food Safety**

**New MRLs and food additive designations**

**2004**

**Approved by:**

![](media/image1.wmf)Kevin Latner

U. S. Embassy

**Prepared by:**

Tetsuo Hamamoto

**Report Highlights:**

Japan invited foreign Embassies to comment on establishment of maximum
residue limits for an insecticide, ethiprole, designation of calcium
stearate, and withdrawal of madder color from the list of food
additives. The deadline for comments is July 21, 2004. This proposal
will be submitted to the WTO for a further opportunity for comments.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Tokyo \[JA1\]

\[JA\]

On June 4, 2004, the Ministry of Labor, Health and Welfare (MHLW)
invited foreign Embassies in Tokyo to comment on; 1) the establishment
of maximum residue limits (MRLs) an insecticide, ethiprole, 2)
designation of calcium stearate, and 3) withdrawal of madder color from
the list of food additives. The deadline for comments is July 21, 2004.

1\) The MRLs for ethiprole shown in Attachment 1 are NOT a part of the
provisional MRLs MHLW is drafting (See GAIN Report JA3071 and JA4051).
MHLW will open the proposal to comments from a wider audience and notify
the WTO SPS Committee before final review and adoption. Ethiprole has
not been registered in either the U.S. or EU.

2\) Calcium stearate may be designated by MHLW with the use standards
and compositional specifications given in Attachment 2.

3\) Based on the fact that madder color had been shown to be genotoxic
as well as carcinogenic to the rat kidney, MHLW will prohibit the use of
the coloring agent and withdraw it from the list of food additives
(Attachment 3).

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

Food Safety and Technical Services

International Trade Policy division

USDA Foreign Agricultural Service

Fax: 202-690-0677

Email: [fstsd@fas.usda.gov](mailto:Freeser@fas.usda.gov)

![](media/image2.png){width="4.604166666666667in"
height="2.1666666666666665in"}

# Attachment 2

###### Calcium Stearate

**[Use Standards (draft)]{.underline}**

No standard is established.

**[Compositional specifications (draft)]{.underline}**

**Definition** Calcium Stearate consists mainly of calcium salts of
stearic acid (C~18~H~36~O~2~) and palmitic acid (C~16~H~32~O~2~).

**Content** Calcium Stearate, when dried, contains 6.4--7.1% of calcium
(Ca= 40.08).

Description Calcium Stearate occurs as a white, light, bulky powder. It
is odorless or has a faint, characteristic odor.

**Identification** (1) To 3.0 g of Calcium Stearate, add 20 ml of
diluted hydrochloric acid (1-2) and 30 ml of diethyl ether, shake
vigorously for 3 minutes, and allow to stand. The separated water layer
responds to test (1) for calcium as described in the Qualitative Tests.

\(2\) Separate the diethyl ether layer obtained in (1), and wash it
successively with one 20-ml potion then one 10 ml-portion of dilute
hydrochloric acid and one 20-ml potion of water. Evaporate the diethyl
ether on a water bath. The melting point of the residue is not lower
than 54°C.

# Purity (1) [Heavy metals]{.underline} Not more than 10 µg/g as Pb.

*Test Solution* Take 1.0 g of Calcium Stearate, heat gently with care at
first, and heat further, gradually rising the temperature to
incineration. After cooling, add 2 ml of hydrochloric acid, and
evaporate on a water bath to dryness. To the residue, add 20 ml of water
and 2 ml of dilute acetic acid, warm for 2 minutes, cool, and filter.
Wash the residue with 15 ml of water, combine the filtrate and washings,
and add water to make 50 ml. Using this solution as the test solution,
perform the test as directed under the Arsenic Limit Test.

*Control Solution* Evaporate 2 ml of hydrochloric acid on a water bath
to dryness, and add 2 ml of dilute acetic acid, 1.0 ml of Standard Lead
Solution, and water to make 50 ml.

\(2\) [Arsenic]{.underline} Not more than 4 µg/g.

Test Solution To 1.0 g of Calcium Stearate, add 5 ml of hydrochloric
acid (1-2) and 20 ml of chloroform, shake vigorously for 3 minutes,
allow to stand, and separate the water layer. Using the water layer as
the test solution, perform the test as directed under the Arsenic Limit
Test. Use apparatus B.

\(3\) [Free fatty acids]{.underline} Not more than 3.0% as stearic acid.

Weigh accurately about 2 g of Calcium Stearate, place to an Erlenmeyer
flask, add 50 ml of acetone, heat in a water bath for 10 minutes with a
condenser attached to the flask, and cool. Filter it with two-ply No. 2
paper filters, wash the inside of the flask, the residue, and the filter
paper with 50 ml of acetone, and combine the washings with the filtrate.
Add 2 to 3 drops of phenolphthalein TS and 5 ml of water, and titrate
with 0.1 mol/L sodium hydroxide. Perform a blank test using a mixture of
100 ml of acetone and 5 ml of water.

1 ml of 0.1 mol/L sodium hydroxide = 28.45 mg C~18~H~36~O~2~

\(4\) [Loss on drying]{.underline} Not more than 4.0% (105°C, 3 hours)

**Assay** Weigh accurately about 0.5 g of Calcium Stearate, place to a
crucible, heat gently with care at first, and then ignite at 700°C for 3
hours in an electric furnace to incineration. After cooling, add 10 ml
of hydrochloric acid to the residue, and warm on a water bath for 10
minutes. Transfer the contents into a flask with the aid of two 10-ml
potions and one 5-ml potion of warm water. Add sodium hydroxide TS until
the solution becomes slightly turbid, and then add 25 ml of 0.05mol/L
EDTA, 10 ml of ammonia-ammonium chloride buffer solution (pH 10.7), 4
drops of eriochrome black T TS, and 5 drops of methyl yellow TS.
Immediately titrate the excess EDTA with 0.05 mol/L magnesium chloride.
The endpoint is when green color of the solution disappears and a red
color is produced. Separately, perform a blank test.

1 ml of 0.05 mol/L EDTA = 2.0039 mg Ca

Regents and solutions

Methyl yellow (Guaranteed)

Methyl yellow TS: Dissolve 0.10 g of methyl yellow in 200 ml of ethanol.

Attachment 3

**Withdrawal of Madder Color, Coloring Agent, out of the List of**

**Existing Food Additives**

**Background**

The Ministry of Health, Labour and Welfare requested the Food Safety
Commission on June 18, 2004 to evaluate the health risk of madder color,
coloring agent. The commission reported on July 2 to the MHLW that the
substance had been shown to be genotoxic as well as carcinogenic to the
rat kidney from the available documents and that no ADI (Acceptable
Daily Intake.) could be established for the substance. The commission
also reported that further evaluations were necessary for organs/tissues
other than the kidney. In response to

the commission's report, the MHLW held a session of the Pharmaceutical
Affairs and Food Sanitation Council on July 5 to hear council's opinion
about the substance. The council concluded that the substance should be
withdrawn from the List of Existing Food Additives. The council also
mentioned that this action should be urgently taken in order to prevent
the occurrence of food safety hazards.

Based on the council's conclusion, the MHLW will prohibit the
production, distribution, and importation of madder color and foods
containing the substance.

# Outline of Legal Action

Based on Article 2-2 Paragraph 1 of the Supplementary Provisions of the
Law to Partially Amend the Food Sanitation Law and the Health Promotion
Law, madder color will be withdrawn from the List of Existing Food
Additives (at about the end of this week), and based on Paragraph 4 of
the same article, this measure will be published in the official
gazette, kanpo. By this legal action, any person will be prohibited from
producing, distributing, and importing the substance and any food
containing the substance. This action will take effect on the date when
the three-month period from the date of publication has passed (early
October). The MHLW will carry out formalities for the WTO notification
as soon as possible.