Ministry of Health, Labour and Welfare

Japanese
Provisional Translation
Original: Japanese

June 3, 2005

Standards and Evaluation Division
Department of Food Safety
Ministry of Health, Labour and Welfare
Division Head: Toshiro Nakagaki
Persons in charge: Miyagawa, Kondo
(Ext. 2486, 2488)

Request for Comments on the Final Draft of Provisional Maximum Residue Limits for Agricultural Chemicals in Foods, toward the Introduction of the "Positive List" System

The Ministry of Health, Labour and Welfare (MHLW) invites your comments on draft provisional maximum residue limits (MRLs) for agricultural chemicals in foods.

In accordance with the Food Sanitation Law (Law No. 233 of 1947), amended by the Law Revising a Part of the Food Sanitation Law (Law No. 55 of 2003), the MHLW is going to implement a so-called "positive list" system for residual agricultural chemicals, including pesticides, veterinary drugs and feed additives (hereinafter referred to as "agricultural chemicals") in foods. This system is designed to prohibit the sale of foods containing residual agricultural chemicals, and is planned to take effect by May 2006.

Toward the introduction of the positive list system, the MHLW has decided to develop provisional maximum residue limits (hereinafter referred to as "Provisional MRLs") concerning agricultural chemicals for those residue limits not specified in the Food Sanitation Law. Draft Provisional MRLs have been discussed and developed by the Subcommittee on Pesticide and Veterinary Drugs of the Food Sanitation Committee under the Pharmaceutical Affairs and Food Sanitation Council (hereinafter referred to as "the Subcommittee"), with reference to the Codex Alimentarius, the relevant international standards, and the registration withholding limits under the Japanese Agricultural Chemicals Regulation Law. The MHLW thus asked for public comments on the First Draft of Provisional MRLs in October 2003. Based on the comments provided, the Second Draft was developed, inviting further public comments in August 2004.

At the same time the Second Draft of the Provisional MRLs was developed, public comments were also invited into the "level having no potential to cause damage to human health" (hereinafter referred to as "the uniform level"), and the "substances that apparently have no potential to cause damage to human health" (hereinafter referred to as "the exempt substances"), a setting which is indispensable for the implementation of the positive list system. With reference to the comments provided, the MHLW has summarized: 1) Response to the Major Comments on the Second Draft of Provisional MRLs, and 2) Response to the Individual Comments on the Second Draft of Provisional MRLs, based on the discussion by the Subcommittee. The Ministry has also developed its final draft of Provisional MRLs, the uniform level, and the exempt substances for agricultural chemicals in foods, toward the introduction of the positive list system.

We are asking for your comments on the final draft of Provisional MRLs the uniform level and the exempt substances that require prompt setting toward the smooth introduction of the positive list system. Please send your comments to us, according to the instructions given below. Please note that the MHLW will not respond individually to each comment.

[Document Lists for Comments]

(1) The Final Draft of Provisional MRLs for Agricultural Chemicals in Foods, toward the Introduction of the Positive List System

(2) The Final Draft of Uniform Level for Agricultural Chemicals in Foods, toward the Introduction of the Positive List System

(3) The Final Draft of Exempt Substances for Agricultural Chemicals in Foods, toward the Introduction of the Positive List System


Instruction for Submission of Comments

1. Comment Period

Friday, 3 June 2005 to Tuesday, 2 August 2005 [Please strictly follow the deadline]

2. Access to the Listed Documents

The documents listed above are available at "Request for Comments on the Final Draft of Provisional Maximum Residue Limits for Agricultural Chemicals in Foods, toward the Introduction of the 'Positive List' System," under the "Topics" in the MHLW website (https://www.mhlw.go.jp/english/index.html).

3. Method of Submission

Please send your comments, accompanied by underlying rationales, to the postal or e-mail address below, using the following forms. Make sure to include the specific title, "Comments on the Final Draft of Provisional MRLs."

Postal address:
   Residual Agricultural Chemicals/Milk, Meat and Fish Regulation,
Standards and Evaluation Division, Department of Food Safety,
Ministry of Health, Labour and Welfare
1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo
100-8916, JAPAN

E-mail address: positivelist2@mhlw.go.jp
   (Residual Agricultural Chemicals/Milk, Meat and Fish Regulation,
Standards and Evaluation Division, Department of Food Safety,
Ministry of Health, Labour and Welfare)
(Text files only)

4. Notes

Comments can be provided in English. Please identify yourself by including your name, address, and occupation. Indicate the name and address of the legal person (company or other organization) if applicable. Please note that submitted information, excluding your address and e-mail information, may be made public.

For details of the positive list system, refer to "Outlines of subcommittee sessions on the implementation of the positive list system and accompanying documents" on the MHLW website. English versions are not available.

For discussion process concerning the implementation of the positive list system at the Pharmaceutical Affairs and Food Sanitation Council, consult the "Subcommittee on Pesticide and Veterinary Drugs of the Food Sanitation Committee under the Pharmaceutical Affairs and Food Sanitation Council" on the MHLW website. English versions are not available.

The rules and standards that have already been established under the Food Sanitation Law are excluded from the target of this comment invitation.

5. Future Plans

The Subcommittee will conduct further discussions before the designated procedure is taken toward the notification of the Provisional MRLs and related standards, taking the obtained comments into consideration.


[Comment Submission Form]

Form 1 (for General Comments)


Address:
Name:
Occupation:

Name of Legal Person:
Location of Legal Person:

[Title]
[Comments]









Form 2 (for Comments on Individual Standards)
Address:
Name:
Occupation:

Name of Legal Person:
Location of Legal Person:

Name/Code of Substance   
Food   
Comments







  

Note: Attach substantiating materials to comments on individual standards.

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