Q. |
What is Malachite Green? |
A. |
Malachite green (MG) is an antifungal agent approved for use in aquarium
fish. It is not approved for use in fish intended for human consumption. MG has been used
in certain countries for the treatment of external fungal and parasitic infections on fish
eggs, fish and shellfish and is an effective fungicide, especially as a general fish
hatchery disinfectant. MG is also used as an industrial dye in some manufacturing
applications, including pulp and paper and textiles. |
Q. |
Is the use of malachite green permitted in Canada? |
A. |
MG is not approved for use in food-producing animals in Canada. The
Government of Canada advised against the use of MG in food fish in 1992. This includes use
during the entire lifecycle of the fish, from the hatchery to the farm. MG is approved in
Canada for use in the treatment of aquarium fish. It is used in a number of manufacturing
applications, including pulp and paper and textiles. |
Q. |
Is eating fish that contains trace levels of malachite green
harmful? |
A. |
Scientific evidence indicates that leucomalachite green, a metabolite of
malachite green, may be a genotoxic carcinogen which persists in fish tissues long after
malachite green can no longer be detected. Health Canada has, however, conducted a
thorough scientific health risk assessment and has determined that the potential risk to
human from eating fish with levels of MG and or LMG residues at 1ppb or lower is remote,
even if fish with these levels are consumed every day, over a lifetime. |
Q. |
What is Health Canada's advice to consumers regarding the
consumption of fish containing trace amounts of malachite green? |
A. |
All fish are an excellent source of high-quality protein and are low in
saturated fat, which make them a healthy food choice. The probability of serious adverse
health consequences from the daily consumption of fish containing trace amounts of MG/LMG
is remote. Consumers should continue to follow a balanced diet in accordance with
Health Canada's Food Guide to Healthy Eating and follow any consumer advisories that may
be issued relating to food by Health Canada, the Canadian Food Inspection Agency and
Provincial or Territorial Agencies. |
Q. |
If malachite green is a potential genotoxic carcinogen, why is it
being permitted in food at any level? |
A. |
Protecting the health of Canadians is Health Canadas primary concern.
Deliberate use of malachite green in food producing animals is not permitted. This is not
changing. In regards to unavoidable exposure to contaminants, Health Canada takes the
position that levels of contaminants should be minimized as much as possible, according to
the ALARA approach (as low as reasonably achievable). Health Canada, the CFIA,
and Fisheries and Oceans Canada will continue work on generating more scientific evidence
through monitoring and testing, and to evaluate gathered data, with the goal of minimizing
exposure even further. |
Q. |
Why not maintain zero tolerance for the presence of malachite green
while the government determines its prevalence in the environment? |
A. |
Health Canadas zero-tolerance policy does remain in place for
deliberative use. While it is unclear to what extent malachite green is present in the
environment, data collected by the Canadian Food Inspection Agency (CFIA) since 2003
indicates that, in certain cases, the trace detection of MG/LMG residues in fish products
are unlikely to be the result of intentional use. Given the sensitivity of some
laboratories testing procedures, a zero-tolerance policy is not achievable or
realistic if a substance is present at background levels in the environment. Canada's
interim approach is a reasonable and achievable way of minimizing public exposure to risks
associated with the presence of MG/LMG at trace levels. It maintains Health Canada's
policy for zero-tolerance for deliberate use of malachite green in food-fish. This also
acknowledges the remoteness of health risks associated with the consumption of trace
amounts of this substance, and the importance of fish as a dietary source for Canadians.
The approach allows for safe, nutritious fish products to be allowed on the Canadian
market. |
Q. |
Why is this an interim measure? |
A. |
The Government of Canada and its provincial/territorial regulatory partners
are putting in place an interim approach to deal with the presence of MG/LMG in fish as
further investigation into the possible sources of the contamination is required. Over the
next year, an interdepartmental working group comprised of Health Canada, the CFIA, and
Fisheries and Oceans Canada will continue work on generating more scientific evidence
through monitoring and testing, and to evaluate gathered data, with the ultimate goal of
minimizing exposure even further. |
Q. |
Do other countries have stricter action levels for the presence of
malachite green? |
A. |
Canadas interim action level is more conservative than action levels
set in other countries, for example, the EU uses 2 ppb as an action level and Japan uses 5
ppb. |
Q. |
What is the significance of Health Canada's interim limit of
quantification (ILOQ) of .5 ppb? |
A. |
Not all laboratories currently testing for MG and LMG in Canada can detect MG/LMG
in fish at equally low levels. Therefore, Health Canada is setting an interim Limit of
Quantification (ILOQ) requiring all laboratories to test to a performance level of .5
parts per billion. This is a scientifically valid, achievable level that allows test
results to be confirmed in all Canadian laboratories testing for MG and LMG residues. |
Q. |
What will be done with fish products found to contain MG or LMG at
levels above 1 ppb? |
A. |
Domestic and imported fish found to contain MG/LMG above 1ppb will not be
allowed for sale in Canada. |
Q. |
What action will the CFIA take on products when detections are below .5 ppb? |
A. |
When MG or LMG is detected in fish products below .5 ppb, the CFIA will not
take regulatory action. The Agency will, however, gather all laboratory test results as
part of the government's collection of data on environmental levels of MG/LMG. |
Q. |
What will happen to products in which MG/LMG is detected between .5
ppb and 1 ppb? |
A. |
For detections of MG/LMG between .5 ppb and 1 ppb, if an investigation
determines MG was used intentionally, this fish will not be allowed to be sold in Canada. |
Q. |
Who will conduct investigations to determine intentional use? |
A. |
Depending on the nature and origin of the product found to contain MG/LMG
at a level between .5ppb and 1 ppb, the responsible authority (provincial/territorial or CFIA)
will conduct the investigation. |
Q. |
Can the CFIA investigate intentional use in imported products? |
A. |
Not directly. For imported product results with levels between .5 and 1
ppb, the importer will have the option of conducting an investigation and providing
evidence that MG has not been deliberately used during the fish production life-cycle. The
CFIA will take action on the product depending on the results of the investigation. |
Q. |
Will product be detained during the investigation? |
A. |
In all cases (domestic and imported), products found to contain MG/LMG at a
range of detection between .5 ppb and 1ppb will be detained or will remain under detection
until an investigation determines whether MG was intentionally used during fish
production. |