Agenda Item 3a) CX/GP 01/3

Introduction

COMISA is the acronym for Confédération Mondiale de l'Industrie de la Sante Animale representing the Global Animal Health Industry. COMISA members are committed to the provision of safe, high quality and effective veterinary drugs to achieve optimum animal health standards which are the prerequisite for the provision of safe, healthy food for consumers.

COMISA would like to reiterate the position that it took in April 2000 whereby it supports the validity of a risk analysis procedure comprising a recognised iterative process which must incorporate precautionary measures in the evaluation steps.

This process is an integral component of the regulatory requirements for the approval of animal health products and is the basis of the evaluations performed by JECFA for the establishment of MRL and ADI values.

COMISA supports the commentary of GCPF referencing the SPS Agreement of WTO providing guidance under Article 5.7. that where relevant scientific evidence is insufficient an ongoing scientific evaluation is a requirement.

Paragraph 34

Under these circumstances, COMISA would propose that the text for paragraph 34 should read:

"… it may be appropriate to apply interim measures to protect the health of consumers, …"

There is no requirement to reference precaution and therefore COMISA continues to maintain the position that Footnote [2] "Some Members refer to the concept as the "precautionary principle" is superfluous and should be deleted.

Paragraph 35

COMISA has no objections to the revised paragraph 35 as identified in CX/GP 01/3. It is proposed to agree to a final detail of the text at the Working Group to be held on 21 April 2001.

March 2001