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DISCUSSION PAPER ON DATA REQUIREMENTS FOR THE ESTABLISHMENT OF MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS FOR MINOR SPECIES (Agenda Item 13)[26]

133. The Committee recalled that at the last session it had agreed that the Delegation of New Zealand would prepare a discussion paper on data requirements for the establishment of MRLs for minor species and that the FAO Secretary to JECFA would present the discussions of the 52nd JECFA on this subject.

134. The FAO Secretary to JECFA presented the discussion paper CX/RVDF 00/14 recalling that few MRLs had been set for so-called “minor species” which caused significant problems for regulatory authorities, and considered practical approaches which could be used to address this issue. The paper considered possible extrapolation from major to minor species and to other species like Salmonidae and bees.

135. The Delegation of New Zealand presented the paper CX/RVDF 00/14-Add.1, which emphasized the need for a risk-based approach in the elaboration and application of MRLs, recalled how the ADIs and MRLs were established, and proposed recommendations for the establishment of generic food group MRLs or specific MRLs where necessary.

136. The Committee expressed its appreciation to the FAO Secretary of JECFA and the Delegation of New Zealand for their important contribution to address a complex issue.

137. Some delegations pointed out that the definition of “minor species” was not clear and that reference should be made to the actual consumption of a species in a specific region to determine its importance. The Delegation of Portugal, speaking on behalf of the member states of the European Union, proposed that the title should refer to “extrapolation of data from one species to another” to avoid the term “minor species”. While comments were made on specific issues, there was general support for many of the concepts raised.

138. The Delegation of Brazil proposed that the consideration of Salmonidae should be extended to all fish species. The Delegation of Thailand proposed that prawn should be considered an aquatic species extended from fish in the development of risk analysis policy concerning the data requirements for minor species.

139. The Delegation of Germany informed the Committee that the CVMP had published guidelines with identical requirements as contained in the CX/RVDF 00/14. The European Community would draw on its experience on this matter to participate in the further development of this document.

140. The Observer from Consumers International expressed the view that some of the extrapolations presented in the documents were not justified scientifically, especially as regards the extrapolation from mammals to fish species, and that Salmonidae should be considered as a “major species”.

141. The Delegation of New Zealand, supported by Thailand, stressed the importance of determining risk assessment policy and proposed to submit the discussion papers to the drafting group that would be considering all aspects of risk analysis, including risk assessment policy, as the basis of work in this area. (see paras 16-19)

142. The Committee agreed to forward both papers to the drafting group on risk analysis for further consideration of such issues as data requirements and extrapolation for incorporation into the general framework of risk analysis.


[26] CX/RVDF 00/14, CX/RVDF 00/14-Add.1, CRD 7 (comments of COMISA), CRD 16 (comments of the EC)

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