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MYCOTOXINS IN FOOD AND FEED (AGENDA ITEM 16) - COMMENTS ON THE DRAFT MAXIMUM LEVEL FOR AFLATOXIN M1 IN MILK (AGENDA ITEM 16A)[46]

86. The 23rd session of the Commission agreed to return the draft Maximum Level of 0.05 mg/kg for Aflatoxin M1 in Milk to step 6 for additional comments and further consideration by the CCFAC, with the understanding that information should be provided on the public health and potential economic implications of a higher level or a lower level as proposed as well as the levels of aflatoxin contamination found in milk.[47]

87. The delegation of Portugal, speaking on behalf of the Member States of the European Union, and other delegations reaffirmed their support for the draft maximum level of 0.05 mg/kg. These delegations noted that aflatoxin M1 was a genotoxic carcinogen, a lower level was needed to protect high level consumers of milk and vulnerable populations such as infants and young children, and that the level proposed was reasonably achievable. These delegations noted that this low level could be easily detected analytically, and that their national intake data indicated that the maximum level could be adhered to. The representative of the EU noted that the level should apply, with appropriate concentration factors, to milk products. It was further noted that those delegations seeking a higher draft maximum level were responsible for providing information to support this.

88. Other delegations expressed opposition to the level of 0.05 mg/kg for various reasons. These delegations noted that the availability, application and costs associated with methods of analysis for the determination of aflatoxins at the lower level were significant. They stated that the risk assessment conducted by the 49th JECFA indicated that the potential carcinogenicity of aflatoxin M1 was approximately ten times less than that of aflatoxin B1. Other delegations therefore stated that a level of 0.5 mg/kg was both reasonably achievable and adequate for the protection of consumer health. They noted that adoption of the lower level would result in severe disruptions to trade in feeding stuffs, loss of valuable nutrients in some countries, that liquid milk for direct consumption was not widely traded and that due to seasonal and regional variations in milk production, aflatoxin M1 levels were difficult to control.

89. The Committee decided to return the draft maximum level of 0.05 mg/kg for Aflatoxin M1 in Milk to step 6 (see Appendix X) for additional comments and consideration at the 33rd Session of the CCFAC. The Committee also requested the submission of information on levels of aflatoxin M1 contamination in milk, potential public health and economic implications of a higher level or a lower level as proposed, as well as an indication of problems encountered in international trade.

90. The Committee also requested the 56th Session of JECFA (February 2001) to examine exposure to aflatoxin M1 and to conduct a quantitative risk assessment to compare both levels in milk.

91. The Committee requested that data on exposure, actual levels found in trade and distribution curves of milk contamination be submitted to JECFA in strict accordance with their data submission deadline of 1 July 2000.


[46] CL 1999/13-GEN and comments submitted by Canada, Malaysia, Norway, United States (CX/FAC 00/16); EC (CRD 4); Argentina, China, Thailand (CRD 5); and India (CRD 6).
[47] ALINORM 99/37, paras. 103-105

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