MAXIMUM LEVEL FOR AFLATOXIN M1 IN MILK
The CCFAC is charged with establishing or endorsing permitted maximum
or guideline levels for naturally occurring toxicants in foodstuffs
and animal feeds.
Aflatoxin M1 is a toxic metabolite of aflatoxin B1.
It is produced in the livers of animals and humans that have ingested
aflatoxin contaminated commodities, primarily cereal grains. It
is normally excreted in the urine and also the milk of dairy cattle
and other lactating mammals. The occurrence of aflatoxin M1
in milk is transitory in nature, usually reaching a peak within
2 days after the ingestion of the contaminated commodity and disappearing
within 4-5 days after the withdrawal of the contaminated source.
The Joint Expert Committee on Food Additives (JECFA) has established
an acceptable level of risk of 0.5 mg/kg for aflatoxin M1
in fluid milk. The International Grocery Manufacturers Associations
(ICGMA) supports this assessment.
The 30th CCFAC forwarded a draft ML of 0.05 mg/kg to the 23rd CAC
(1999) for adoption at step 8. However, the CAC could not reach
a consensus and returned the Draft ML to the CCFAC for further consideration
in regards to the public health and the potential economic implications
of a higher or lower level than the proposed 0.05 mg/kg.
The 32nd CCFAC (March 2000) requested JECFA to conduct a quantitative
risk assessment at its 56th Session to compare the levels of 0.05
mg/kg and 0.5 mg/kg using monitoring data from all regions of the
world. The 33rd CCFAC (2001) discussed the summary report of the
56th JECFA (2001). The summary report showed that the additional
risk for liver cancer predicted for an ML between 0.05 to 0.5 mg/kg
was negligible. The JECFA representative commented that the data,
as analyzed, assumed that all milk was contaminated; if a distribution
analysis of the data had been used, the risk would be even smaller.
The 33rd CCFAC forwarded an ML of 0.5 mg/kg M1 in milk
to the CAC, based on:
(a) Risk assessment by the JECFA;
(b) A level of 0.5 mg/kg was both adequate for the protection
of consumer health and reasonably achievable for all countries,
(c) a reduction in the maximum level might entail a significant
reduction in the availability of milk in developing countries
and therefore would have negative implications from a nutritional
point of view; and
(d) The level of 0.05 mg/kg seemed not to be achievable in some
regions of the world.
ICGMA supports establishing an ML of 0.5 mg/kg for aflatoxin M1
in milk because:
Risk assessments conducted by the US FDA support establishment
of an ML of 0.5 mg/kg M1 in milk. The most recent assessment
revealed an insignificant upper bound lifetime risk even for 90th
percentile “eaters-only” group. This upper bound risk
estimate indicates that the US system, which relies on a combination
of good agricultural and good manufacturing, practices and FDA’s
action level of 0.5 mg/kg for aflatoxin M1 in milk
provides adequate public health protection.
Aflatoxin risk assessment performed by the 49th (1997)
and 56th JECFA (2001), support the level of 0.5 mg/kg as being
adequate to protect public health. The JECFA noted that no significant
public health gain would be achieved by setting a level lower
than 0.5 mg/kg for aflatoxin M1 in milk. JECFA compared
the predicted risk reduction under worst case assumptions (life
time exposure to all milk at the highest level) at MLs of 0.05
and 0.5 mg/kg and concluded that the additional risks were insignificant.
The Codex’s health and safety decisions should
be grounded on science based risk assessments. Therefore, setting
an ML for M1 in milk other than 0.5 mg/kg would be
inconsistent with Codex’s stated principles of establishing
standards based on risk assessments.
In regions of the world where low levels of aflatoxins
are virtually unavoidable in grains used for dairy feed, an ML
of 0.5 mg/kg for aflatoxin M1 in milk is practical
and allows an adequate supply of rations for milk producing animals.
Endorsement of an ML below 0.5 mg/kg is technically difficult
for many regions of the world to achieve and could comprise the
availability of healthy and productive milk producing animals
and adequate supplies of milk for human nutrition.
An ML below 0.5 mg/kg for aflatoxin M1 in
milk could have a negative public health effect by reducing the
availability of a safe, low cost food that is a good dietary source
of high quality protein, calcium and other valuable nutrients.
Reduction in availability of otherwise safe milk could also create
an unnecessary health risk by depriving infants and young children
of a dietary source of essential nutrients necessary for normal
growth and development.
The imposition of a maximum level less than 0.5 mg/kg
would restrict international trade of feed ingredients because
the level of aflatoxins in the feed would need to be controlled
to lower levels than currently used in order to assure that the
milk met the lower standard. This issue is further complicated
by the fact that the animals for which the feed components will
be used are not known at the time of international shipments.
Therefore, the milk level may result indirectly in an unwritten
lower limit for aflatoxins in feed ingredients for all animals,
even though animal feed is a good use of the more aflatoxin contaminated
ingredients for many animal species without significant risk to
the animals or consumers from derived foods.
The International Council of Grocery Manufacturers Associations
is an international non-governmental organization (NGO) officially
recognized by the Codex Alimentarius. ICGMA represents the interests
of national and regional associations representing all sectors of
the grocery industry and serves to facilitate harmonization of standards
and policies concerned with health, safety, packaging, labeling,
advertising and marketing of foods, beverages and other grocery