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Position Paper
MAXIMUM LEVEL FOR AFLATOXIN M1 IN MILK

March, 2000

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 products.