Request for Comments on the Second Draft of Provisional Maximum Residue Limits for Agricultural Chemicals in Foods

20 August 2004

Standards and Evaluation Division
Department of Food safety
Ministry of Health, Labour and Welfare

Request for Comments on
the Second Draft of Provisional Maximum Residue Limits for
Agricultural Chemicals in Foods

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

The MHLW is going to implement a so-called "positive list system"- a system to prohibit the distribution of foods that contain agricultural chemicals above a certain level if maximum residue limits (MRLs) have not been established. The agricultural chemicals include pesticides, veterinary drugs and feed additives. This activity is based on the revised Food Sanitation Law published in May 2003. The system will take effect within three years after the publication of the revised law.

The MHLW asked for public comments on the First Draft of Provisional MRLs last October. With reference to the obtained comments to the first draft the Subcommittee on Pesticide and Veterinary Drugs of the Food Sanitation Committee under the Pharmaceutical Affairs and Food Sanitation Council, an advisory scientific expert group to the Minister, has considered further on the provisional MRLs and other issues relevant to the positive list system.

The MHLW's responses to the public comments- 1) Response to the Major Comments on the provisional MRLs(PDF:91KB), 2) Response to the Individual Comments (available only in Japanese ), and 3) Response to the Comments on Individual Substances (available only in Japanese )-can be found at the MHLW web site.

The second draft provisional MRLs are based upon the opinion from the Subcommittee on Pesticide and Veterinary. The list of draft provisional MRLs is attached to this document.

We are asking for your comments on the draft MRLs and other documents listed below in order to facilitate the implementation of the positive list system. Please send your comments to us, according to the instruction given below. Please note that the MHLW will not respond individually to each comment.

( Document Lists for Comments )

-		The Second Draft of Provisional Maximum Residue Limits (MRLs) for Agricultural Chemicals in Foods
-		Regarding Establishment of the "level to be determined by the Minister of Health, Labour and Welfare, at the Pharmaceutical Affairs and Food Sanitation Council's advice, as that having no potential to cause damage to human health"as Specified in Article 11, Paragraph 3 of the Food Sanitation Law (Draft)(PDF:63KB)
-		Regarding Establishment of the "substances to be determined by the Minister of Health, Labour and Welfare as those that apparently have no potential to cause damage to human health"as specified in Article 11, Paragraph 3 of the Food Sanitation Law (Draft)(PDF:50KB)

( How to Read "the Second Draft of provisional MRLs" )

The Second Draft contains following documents.

-		"The Second Draft of Provisional Maximum Residue Limits (MRLs) for Agricultural Chemaicals in Foods"(hereinafter referred to as "the Text")
-		"General Provisions to Enforce the Positive List System"(hereinafter referred to as "General Provision")
-		Table 1 Agricultural chemicals shall not be detected in any foods
-		Table 2 Second Draft of Provisional Maximum Residue Limits (MRLs)
-		Table 3 Provisional MRLs in processed foods
-		Note: List of pesticides and veternary drugs for which MRLs are currently established and no provisional MRLs are proposed

The Text explains legal background and procedures to be followed in development of the second draft of the provisional MRLs.

General Provision shows a proposal on horizontal rules for enforcement of provisional MRLs. This will be published as legal texts in the Official Gazette.

Table 1 lists the substances not detected in any foods. The analytical methods and their levels of detection (LOD) will be published in the Official Gazette.

Table 2 shows provisional MRLs of Agricultural Chemicals. The substances, for which MRLs are currently established and no provisional MRLs are proposed, are listed in the Note. When the positive list system is enforced, MRLs in Table 2 and Note will be enforced.

In Table 2 the changes from the First Draft are shown in Bold and Italic.

Table 3 shows MRLs for processed foods which are based upon the MRL in the Codex Alimentarius. In the cases of the processed foods other than those in Table 3, the provision of paragraph 6 in the General Provision is applied.

Instruction for submission of comments

Comment Period: From 20 August 2004 to 30 November 2004

Necessary information:

>Please send your comments, accompanied by rationales including underlying documents, to the mailing address or e-mail address given below. Comments are preferably in Japanese.

>Make sure to include the specific title: "Comments on the first draft of provisional MRLs."Submissions by phone will not be acceptable.

>Please identify yourself by including your name, address, and occupation. In the case of a legal person (company or other organization), indicate the name and address of the legal person. Please note that submitted information, excluding your identity, may be made public.

Address:

Mail:	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:	positivelist@mhlw.go.jp

Outlines of subcommittee sessions on the implementation of the positive list system and accompanying documents are accessible at the MHLW web site. The English versions are not available.

Information on MHLW development on analytical methods for positive list system is also available at the web site.

Future business

The Subcommittee on Pesticides and Veterinary Drugs will conduct further discussion before the provisional MRLs are finalized, taking the obtained comments into consideration.
In addition the MHLW will ask the Food Safety Committee for comments on "level to be determined by the Minister of Health, Labour and Welfare, at the Pharmaceutical Affairs and Food Sanitation Council's advice, as that having no potential to cause damage to human health"according to the provision of Article 23 of the Food Safety Basic Law. The MHLW will then notify the WTO in accordance with the necessary formalities, and also seek public comments on the final draft provisional MRLs.