3rd Report of the Market Access Ombudsman Council (March 18, 1996)

1-(3) Review of Designation System for Animal Feed Additives

1. Complainant: Japan Foreign Trade Council

2. Ministry concerned: Ministry of Agriculture, Forestry and Fisheries

3. Background Information:

Under the Law concerning Safety Assurance and Quality Improvement of Feed, the Minister of Agriculture, Forestry and Fisheries has the authority to establish standards for the methods of manufacturing, using, preserving feed additives, or labeling their quality, or the authority to establish specifications for their ingredients, in order to prevent the production of harmful livestock products or hindrance to the production of livestock products through damage to livestock, due to the use of feed containing feed additives. The Minister is required to ask for the recommendation of the Agricultural Materials Council in establishing or revising these standards.

The evaluation guideline for feed additives that serve as an indicator for the deliberation at the Agricultural Materials Council is provided by the "On the Establishment of Standards for Evaluation of feed Additives," which also requests the preparation of reference materials necessary to prove that a feed additive meets the required conditions and provides an outline on how to conduct the principal tests for preparing the reference materials (hereinafter referred to as the "Guideline").

The Guideline prescribes that a feed additive used to "promote the effective use of nutrition in the feed" be tested for its effectiveness (field effectiveness test using the target animal) at no less than one domestic facility.

4. Complaint:

The complainant raised the following issue with the field effectiveness test of feed additives.

As a condition for having foreign feed additives designated, part of the field tests must be conducted in Japan. The time and expenses required for this requirement hinders timely access to the market and presents the danger of giving domestic manufacturers some advantage. Therefore, the current system should be reviewed, for example, to accept as official data such foreign data as those from tests conducted in line with EC directives.

5. Results of Deliberation:

The ministry concerned plans to continue to deliberate the review of the Guideline by taking into account the purport of the complaint. The meeting of the Examination Committee on the Effect and Safety, Agricultural Materials Council was held in November 1995 and confirmed that the examination of the review of the field effectiveness test under the Guideline would start in fiscal year 1996. As for the simplification of domestic tests by accepting foreign data, paying enough attention to ensuring safety of feed additives, the results of the deliberations at the Agricultural Materials Council should be compiled within fiscal year 1996, and then action should be taken based thereon.

Government decision (March 26, 1996)

1-(3) Review of Designation System for Animal Feed Additives

As for the simplification of domestic tests b accepting foreign data, paying enough attention to ensuring safety of feed additives, the results of the deliberations at the Agricultural Materials Council should be compiled within fiscal year 1996, and then action will be taken based thereon.

Follow-up (May 12, 1997)

1-(3) Review of Designation System for Animal Feed Additives

After deliberation by the safety sub-committee of the feed committee in the Agricultural Materials Council, the committee replied at its 18th meeting on February 5, 1997, that the guidelines ("On the Establishment of Standards for Evaluation of Feed Additives") would be reviewed based on revision of the OECD Committee's "OECD Rules on Chemical GLP (measures guaranteeing the reliability of test results on the safety and toxicity of chemical substances).

After deliberation by the Committee and its recommendations, the guidelines (directive issued jointly by the heads of the Livestock Industry Bureau and of the Fisheries Agency) will be revised promptly during FY1997.