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Comments on the Draft Maximum Level for Aflatoxin M1 in Milk (Agenda Item 15a)[50]

MYCOTOXINS IN FOOD AND FEED (Agenda item 15)

127. The 32nd CCFAC decided to return the draft maximum level of 0.05 µg/kg for Aflatoxin M1 in Milk to Step 6 for additional comments and consideration at its 33rd Session. The 32nd CCFAC also requested the 56th Session of JECFA (February 2001) to examine exposure to Aflatoxin M1 and to conduct a quantitative risk assessment to compare the levels of 0.05 µg/kg and 0.5 µg/kg in milk.[51]

128. Several delegations and the Representative of WHO stressed the importance of receiving monitoring data from all regions, as most data for Aflatoxin M1 in milk were submitted by the Member States of the European Union. It was noted that FAO and WHO have programmes in place to provide technical assistance to developing countries for surveillance and monitoring.

129. Several delegations expressed their concern about the level of 0.5 µg/kg for Aflatoxin M1 because in the case of genotoxic carcinogens, exposure at any level might pose a health risk to consumers, and the level should therefore be as low as reasonably achievable. These delegations indicated that most data sent to JECFA showed that the level of 0.05 µg/kg was achievable. The Delegation of Sweden, speaking on behalf of the member states of the EU, stressed that the level of 0.5 µg/kg was higher than the current level in the EC and that it would not be acceptable to their consumers in view of health concerns.

130. Other delegations pointed out that the report of the JECFA showed that the additional theoretical risk for liver cancer predicted when moving from 0.05 to 0.5 µg/kg was negligible. The WHO Secretary to JECFA commented that the analysis assumed that all milk was contaminated and that if a distribution analysis was used, the risk would be even smaller. Some delegations noted that the level of 0.05 µg/kg seemed not to be achievable in some regions of the world and that a level of 0.5 µg/kg was both adequate for the protection of consumer health and reasonably achievable for all countries. It was also stated that 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.

131. Some delegations proposed to discontinue consideration of Aflatoxin M1 in milk, as there was no consensus on the level proposed and because international trade in fresh milk was limited. Other delegations pointed out that international trade in milk-derived products was quite substantial and that it was therefore appropriate to set a level for Aflatoxin M1 in milk to ensure consumer protection.

Status of the Draft Maximum Level for Aflatoxin M1 in Milk

132. The Committee forwarded the draft Maximum Level of 0.5 µg/kg for Aflatoxin M1 in Milk to the 24th Session of the Commission for adoption at Step 8 (see Appendix X). The delegation of Sweden, speaking on behalf of the Member States of the European Union present at the session (Ireland, France, Belgium, Denmark, Italy, Portugal, Spain, Sweden, Germany, Austria, Finland, the United Kingdom, the Netherlands), and the delegations of Czech Republic, Hungary, Republic of Korea, Norway, Poland, Slovak Republic, South Africa and Switzerland, expressed their reservation to this decision for those reasons mentioned above. The Observer from Consumers International also expressed its disagreement with this decision.

Other matters

133. The Committee agreed that further consideration should be given to the following issues in the case of genotoxic carcinogens: the definition of risk assessment policy; the relationship between the risk assessment and the risk management options, especially the ALARA concept; and, risk communication issues, including consumer perception. For this purpose, the Committee requested FAO and WHO to jointly organise a Seminar in conjunction with the 34th CCFAC in order to facilitate a better understanding of these complex issues.


[50] Comments submitted in response to CL 2000/10-FAC from Canada, Norway, EC (CX/FAC 01/20) and Norway, Spain, Uruguay (CRD 10)
[51] ALINORM 01/12, paras. 89-90 and Appendix X

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