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Statement on the safety assessment of the exposure to lutein preparations based on new data on the use levels of lutein

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Following a request by EFSA, the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) carried out a new exposure assessment of lutein (E 161b) as a food colour, based on corrected data provided by the food industry. In 2010 the ANS Panel estimated at Tier 3 the exposure to lutein as food colour to exceed the ADI of 1 mg/kg bw/day at the upper end of the range. In 2011, industry provided EFSA with corrected use levels of lutein. The Panel considered that the new use levels are significantly lower than the ones provided previously and thus would have an important impact on Tier 3 exposure estimates. The new Tier 3 estimates result in an exposure to lutein of European adults of 0.1 mg/kg bw/day at the mean and of 0.3 mg/kg bw/day at the 97.5th percentile. These values are lower than the previously reported exposure estimates at Tier 3. The corresponding reduction of refined exposure estimates at Tier 3 for European children, range from 0.1-0.4 mg/kg bw/day at the mean and from 0.1-1.0 mg/kg bw/day at the 95th/97.5th percentile. In 2010 the estimated exposure at Tier 2 for adults was 0.8 mg/kg bw/day (mean) and 3.2 mg/kg bw/day (95th percentile) and, for children between 0.5 to 3.4 mg/kg bw/day (mean) and 1.2 to 7.2 mg/kg bw/day (95th percentile). Combining the estimated intakes of lutein from the diet and from its use as food colour leads to an overall exposure of adults not exceeding the ADI of 1 mg/kg bw/day at the mean and 95th percentile, which is in contrast to the previous exposure assessment. For children, the ADI would also not be exceeded at the mean, but would be exceeded at the 95th/97.5th percentile in The Netherlands and, UK.