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The Japan Food Chemical Research Foundation
Guideline for Establishment of MRLs
Last updateF06/27/2011

The following documents on "Guideline for Application for Establishment and Revision of Maximum Residue Limits for Agricultural Chemicals used outside Japan" were officially announced by Ministry of Health, Labour and Welfare (MHLW).

Original: Japanese
Provisional Translation
Guideline for Application for Establishment and Revision
of Maximum Residue Limits for Agricultural Chemicals
used outside Japan

I. Purpose

This guideline outlines the procedures required to apply for the establishment and revision of maximum residue limits (MRLs) for agricultural chemicals on/in foods, and the scope of required documents. The guideline targets agricultural chemicals --- pesticides, veterinary drugs, and feed additives --- that are approved in the foreign countries for foods exported to Japan. The foods include agricultural products, animal products, or seafood.

The requirements given in this document notwithstanding, it is not necessarily appropriate to require a uniform set of documents for every chemical. Also, advances in science and technology may bring new analytical and evaluation methods. Therefore, the study results and related documents given in the guideline can be replaced by other documents sufficient to conduct evaluation for establishment and revision of MRLs.

II. Procedures for Establishment and Revision of MRLs for Agricultural Chemicals

1. Application

Any person may apply to the Minister of Health, Labor and Welfare with Form 1 or 2 for the establishment or revision of MRLs for an agricultural chemical in the case that the chemical is approved in a country for foods exported to Japan. The Form should be accompanied by required documents on the chemical including data as described in the section III.

If the applicant is abroad, an appropriate contact person in Japan should be identified to handle the application. The Form should be submitted to the Standards and Evaluation Division, the Department of Food Safety, MHLW.

2. Evaluation

The submitted application will first be examined by the secretariat of the Division. Then, the risk assessment on the chemical will be done by the Food Safety Commission, based on Article 24, Paragraph 1, Item 1 of the Food Safety Basic Law. Draft MRLs will be discussed at the Pharmaceutical Affairs and Food Sanitation Council, based on the Commissionfs assessment.

The Commission and Council may ask for additional documents/data from the applicant if necessary.
In response to the Councilfs report, the secretariat will take necessary procedures including the WTO notification and prepare for publication on the establishment or revision of MRLs, based on Article 7 Paragraph 1 of the Food Sanitation Law.

III. Required Documents

1. Data Sets and GLP Compliance

A. Data Sets

The data sets required when applying for the establishment and revision of MRLs are given below. Besides them, other data on safety assessment should be submitted if available.

a. Establishment of MRLs

b. Revision of MRLs

Residue data on target foods --- agricultural products, animal products, or seafood. If new findings on safety and residue of the applied chemical have been obtained after MRLs were established for the chemical, documents on the findings should be submitted. The applicant must have toxicity data, but the submission shall be made upon request of the MHLW.

B. GLP Compliance

In principle, studies mentioned the above "A" should comply with the GLP requirements.
If data are quoted from studies not conducted by the applicant, prior permission should be obtained from the study authors unless they have been publicized in scientific journals.

C. Language

The executive summary should be in Japanese. Other accompanying documents, such as study reports may be written in English. Documents in other languages are not acceptable.

2. Additional Data

If the MHLW determines additional study data as necessary in discussion for the establishment or revision of MRLs, the applicant may be requested to submit them.

3. Other Requirements

The following documents should be submitted.

If the chemical residue may be decomposed, migrated, or concentrated in the process of manufacturing or cooking (especially, in cereal grains and oil seeds), the submission of processing data is desirable.

If the registration of the target chemical is revoked overseas or the registration is withdrawn after Japan establishes its MRLs, the applicant should inform them to the MHLW.

Note: Australia, Canada, EU, New Zealand, the US, where the establishment of MRLs is based on toxicity data equivalent to those needed for scientific evaluation by the JMPR or JECFA.