140. The 32nd Session of the CCFAC decided to return the proposed draft maximum level of 5 µg/kg Ochratoxin A in Cereals and Cereal Products to Step 3 for additional comments[55].
141. The Committee noted that JECFA performed a risk assessment on the levels of 5 and 20 µg/kg Ochratoxin A in cereals and cereal products at its 56th meeting (February 2001) as requested by the 31st Session of the CCFAC and concluded that the mechanism of carcinogenicity was unknown. The JECFA Secretariat noted that further studies were underway on this issue and that Ochratoxin A should be evaluated in 2004. The JECFA meeting therefore retained the previously established PTWI of 100 ng/kg body weight per week. The 95th percentile of cereal consumers would have an intake close to the PTWI, regardless of which limit of (5 or 20 µg/kg) Ochratoxin A was employed in intake calculations for cereals and cereal products. The JECFA Secretariat noted that the difference in exposure at these two levels, on the basis of available data, were not significant. The Committee also noted that most data originated from Europe because contamination with Ochratoxin A in cereals was more frequent in that region.
142. The Delegation of the United States, supported by several delegations, indicated that because the difference in health risk between the two proposed limits was negligible, a level of 20 µg/kg could be adequate in terms of food safety. Moreover the Delegation noted that wheat and barley were the major contributors to Ochratoxin A intake, while the contribution of other cereals to total intake was less significant and did not justify the establishment of a maximum level applicable to all cereals.
143. The Delegation of Sweden, speaking on behalf of the members states of the EU, and the Observer of Consumers International, stressed that insofar as intake due to cereal consumption was close to the PTWI, and because many other foodstuffs contributed to total ochratoxin intake, the level should therefore be kept as low as possible. The Delegation also indicated that rye contributed significantly to ochratoxin intake in Europe. Some delegations indicated that the levels found in cereals in Europe would justify setting an even lower level in cereal products such as 3 µg/kg.
144. After an extensive discussion, the Committee agreed that it would be generally acceptable and practically achievable to establish a maximum level of 5µg/kg for Ochratoxin A in the cereals wheat, barley and rye and derived products.
Status of the Proposed Draft Maximum Level for Ochratoxin A in Wheat, Barley and Rye and Derived Products
145. The Committee agreed to forward the proposed draft maximum level of 5 µg/kg for Ochratoxin A in Wheat, Barley and Rye and Derived Products to the 24th Session of the Codex Alimentarius Commission for adoption at Step 5 of the Procedure (see Appendix XII).
