Summary report of Codex Alimentarius meeting on biotechnology, 4-8 March 2002

March 21, 2002

Brussels, 20 March 2002

3rd Session of Codex Task Force on Biotechnology (Yokohama (Japan), 4-8 March 2002) - summary report. Note from the General Secretariat to the Codex Alimentarius Working Party. Brussels, 18 March 2002 (document 7166/02 CODEX 11). Full text

I. INTRODUCTION

The 3rd meeting of the Codex Task Force on Foods derived from Biotechnology took place in Yokohama, Japan. The session was opened by Mr Jyungoro Kondo, Vice Minister for Health, Labour and Welfare of Japan and chaired by Professor Hiroshi Yoshikura, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, of Japan.

The session was attended by 35 government's representatives and 15 international observer organisations. All Member States of the EU (except Austria, Greece, Luxembourg and Portugal) and the European Commission were represented.

Prior to the session, a preparatory meeting was held in Brussels on 12 February 2002. In this meeting the Codex Working Party discussed about the strategy and the approach to be taken by the EC and its Member States in relation to various agenda items (see document 6211/02).

The Spanish Presidency convened the Working Party several times, every day, on the spot in Yokohama.

Pending the circulation of the Codex Secretariat's official report (ALINORM 03/34), this document summarises the main discussions and conclusions of the session from the Community viewpoint.

II. BACKGROUND TO THE DISCUSSIONS

It is to be recalled that the Task Force was mandated by the Codex Alimentarius Commission (CAC) in 1999 to present to the CAC in 2003 for adoption:

* a set of general principles dealing with essential risk management aspects of foods produced by biotechnology

* a set of specific guidelines on the safety and nutritional assessment of these foods.

In addition to this, the 2nd session of the Task Force agreed to initiate new work in the following areas:

* Consideration of a draft annex on allergenicity assessment to be attached to the draft guidelines document,

* Consideration of a guideline for conduct of food safety assessment of recombinant DNA microorganisms in food.

[It should be noted that the Task Force has a limited mandate and will cease to exist in 2003.]

After receiving approval to begin work in these two new areas by the 24th Session of the CAC, the Ad Hoc open-ended working group on Allergenicity met in Vancouver, Canada from 10-12 September 2001 to develop an annex relating to allergenicity. The open-ended working group on microorganisms in food was held from 6-9 November 2001 in Oakland, California, in order to produce a draft guideline text.

Against this background it is clear that the Task Force has a heavy agenda but a limited mandate. To enable the Task Force to get through its programme, a working group on analytical methods under the chairmanship of Germany, was held before and during the session. The Task Force also instructed an informal ad hoc working group to consider traceability.

III. MAIN CONCLUSIONS OF THE SESSION

Draft General Principles for The Risk Analysis of Foods Derived From Modern Biotechnology (item 4)

>From the EC point of view the outcome of the discussions on the Principles document could be regarded successful. Following negotiations on this document, a number of technical changes were introduced. The EC broadly endorsed these changes. However, the main part of the discussions in the Task Force were devoted to the issue of traceability (see also item 7).

The Task Force examined in detail the proposed text for paragraph 21. Divergent views were expressed on this paragraph. Following very intensive negotiations, the Task Force felt that the resolution of this issue was important in order to reach a final conclusion on the text of the Draft Principles. It noted that the new paragraph 21 made it possible to place the question of traceability into context as one of the tools for implementation and enforcement of risk management measures, without prejudice to its use for other purposes. On this basis a compromise text was agreed to as follows:

Specific tools may be needed to facilitate the implementation and enforcement of risk management measures. These may include appropriate analytical methods; reference materials; and, the tracing of products for the purpose of facilitating withdrawal from the market when a risk to human health has been identified or to support post-market monitoring in circumstances as indicated in paragraph 20.

[It is recognised that there are other applications of product tracing. These applications should be consistent with the provisions of the SPS and TBT Agreements. The application of product tracing to these areas covered by both Agreements is under consideration within Codex on the basis of the CCxec decisions at its 49th session.]

Following an agreement on this sensitive issue, the Task Force agreed to send the proposed Draft Principles document to Step 8. This outcome was satisfactory to the EC and to the Task Force who reached this landmark decision in a record time (i.e. 3 years). The agreement on traceability was significant as it will also facilitate the work in other Committees.

Draft Guideline for the Conduct of the Safety Assessment of Foods derived from Recombinant-DNA Plants (item 5a)

The Task Force examined the above-mentioned Guidelines document. Several changes were made. Following these modifications, the Task Force agreed to advance the Proposed Draft guideline document to step 8 for the consideration by the CAC.

Draft Annex on the Assessment of Possible Allergenicity (item 5b)

An open-ended working group on Allergenicity, led by Canada, introduced the revised Annex. The working group discussed the Annex and introduced several changes to it.

After these changes, the Task Force agreed to forward a Draft Annex on the Allergenicity to the CAC for adoption at Step 5 and recommended that the CAC also adopt the Annex at Step 8, by the omission of Steps 6 and 7.

Draft Guidelines for the Conduct of Food Safety Assessment of recombinant-DNA Microorganisms in Food (item 6)

Due to time constraints, the Task Force made a number of editorial changes and corrections for clarity and also approved proposals from delegations to provide guidance for the continued elaboration of the above-mentioned document.

The Task Force noted that although there had been many proposals for change to individual paragraphs in the text, the general approach and outline of the text was accepted. It also noted that most of the text proposed by the working group had proved to be acceptable to the Task Force. Against this background it decided to advance the Draft Guidelines on microorganisms to Step 5 for consideration of the next session of the Executive Committee.

Discussion Paper on Traceability (item 7)

In view of the compromise reached on this issue in the context of the Draft General principles (see item 4), the Task Force decided not to have a discussion on traceability at this time. It agreed however to have a more detailed discussion at its next session, but also agreed that such a discussion should not compromise the consensus that had already been achieved in the Draft General Principles and should not lead to specific recommendations or guidelines.

Analytical Methods (item 8)

The 1st session of Task Force established a working group on analytical methods under the chairmanship of Germany. This group met again before and during the plenary session.

The Task Force agreed on the basis of a recommendation by the working group:

* to forward to the CCMAS for its consideration the list of methods elaborated from the information reported by member countries

* to propose to CCMAS to consider further methods of analysis with respect to food derived biotechnology on the basis of the proposal from member countries

* to propose through CAC that FAO, WHO and the FAO/IAEA Joint Division for Nuclear Techniques in Food and Agriculture encourage the development and maintenance of information of methods under development or not yet validated in co- operation with national/regional institutions.

Place and date of the next session

The Fourth (and the final) meeting of the Task Force was tentatively scheduled to be held in Yokohama, Japan from 10 to 14 March 2003. According to the latest information this session could be shortened by one day.

IV. EUROPEAN REGION MEETING

The European Region informal meeting relating, in particular to traceability, took place in Yokohama, Japan with the participation of the Czech Republic, Hungary, Norway and Switzerland.

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