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Interim Guidelines for the Presence of Malachite Green (MG) and Leucomalachite Green (LMG) in Aquaculture Fish Products

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29 March 2006

TO: ALL IMPORTERS AND FEDERALLY REGISTERED PROCESSERS OF FISH AND SEAFOOD PRODUCTS

SUBJECT: INTERIM GUIDELINES FOR THE PRESENCE OF MALACHITE GREEN (MG) AND LEUCOMALACHITE GREEN (LMG) IN AQUACULTURE FISH PRODUCTS

Health Canada has developed an interim guideline to address the presence of trace amounts of the unapproved substance malachite green (MG) in some domestic and imported aquaculture fish products.

Malachite green is not permitted in Canada for use during any part of the aquaculture fish production life-cycle.

The interim guidelines from Health Canada and CFIA’s product acceptability criteria are described below:

MG or LMG levels	Product action
> 1.00 ng/g (ppb) for MG or LMG	Product is unacceptable. Appropriate regulatory actions will be taken.
>0.50 ng/g (ppb) to 1.00 ng/g (ppb) for MG or LMG Gathering of information will be required to determine deliberate use	Product is unacceptable unless a review of information gathered shows there has been no deliberate use. Appropriate regulatory actions will be taken, as required.
0.50 ng/g (ppb) - Interim Limit of Quantification for MG or LMG	Product with levels 0.50 ng/g (ppb) for MG or LMG - no regulatory actions will be taken.

The minimum performance level of the laboratories testing for MG or LMG must meet the limit of quantification of 0.5 ng/g (ppb) for MG or LMG.

The interim guidelines above will apply equally to imported and domestic fish products.

For products found to contain levels > 0.50 and 1.00 ng/g (ppb) of MG or LMG, the following approach will be used:

Importers will have the option of gathering information in order to provide evidence of non-deliberate use. The importers should contact the local CFIA office. On a case by case basis, the CFIA will determine when the option for gathering information is available. This will be based on the importer’s Quality Management Program and/or on the presence of foreign arrangements or regulatory links with the respective foreign authorities. CFIA will take the appropriate regulatory action.

Federally registered processors will be required to notify the CFIA of these results and take the appropriate corrective actions according to their QMP plan. Appropriate corrective actions should include gathering information to determine if deliberate use of MG occurred during any part of the aquaculture fish production life cycle. The processor will provide their findings to the CFIA and the information will be reviewed to determine the regulatory compliance. The CFIA may complete a Compliance Verification to determine whether the QMP requirements have been met.

If you have questions, please contact your local CFIA fish inspection office or Mr. Alf Bungay, National Manager, Inspection Systems and HACCP, Fish Seafood and Production Division at (613) 221-7026.

Sincerely,

original signed by

Mary Ann Green
Director
Fish, Seafood and Production Division
Animal Products Directorate
Canadian Food Inspection Agency