My Nutrition World.net

The European Food Safety Authority (EFSA) released a new statement on the safety of lycopene. The statement reconfirmed that the Acceptable Daily Intake (ADI) of 0.5 mg per kilogram of bodyweight per day (0.5 mg/kg bw/day) previously established still holds relevant.

This assessment covers lycopene consumed from all food sources, including lycopene contained naturally in fruits and vegetables, as well as lycopene used as a food additive.

The July statement was presented because the European Commission had asked EFSA’s ANS Panel (Panel on Food Additives and Nutrient Sources Added to Food) to reconsider whether EFSA’s ADI needed to be revised. This was due to the fact that the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which in 2006 had set the same 0.5 mg/kg bw/day ADI for lycopene, in 2009 declared a “not specified” ADI for lycopene when used as a food colorant.

The ADI originally set by both EFSA’s Panel on Food Additives, Flavorings, Processing Aids, and Materials (AFC) and JECFA was based on a one-year rat study. The study saw elevated levels of serum aspartate transaminase (AST) and alanine transaminase (ALT) in lycopene doses ranging from 50 to 250 mg lycopene/kg bw/day. Using an uncertainty factor of 100, the panels at the time set a level of safety at 0.5 mg/kg bw/day.

In its July statement, EFSA said that the discrepancy between EFSA’s original evaluation and JECFA’s new evaluation was mainly based on a “diverging interpretation” of the toxicological relevance of the AST and ALT levels in the one-year rat study. EFSA said that JECFA hadn’t evaluated any new evidence that would cause EFSA to reevaluate its ADI.

The difference arose because the new JECFA evaluation deemed the elevated AST and ALT levels seen in the rat study to be non-adverse because of “lack of concordance with other important measures usually associated with liver damage, such as increased organ weight and histopathology.”

In its July statement, EFSA said that it, however, stood by its opinion that there may be a level of risk associated with a minimum dosage of 50 mg lycopene/kg bw/day, as seen in the rat study. Therefore, EFSA reconfirmed the previously established 0.5 mg/kg bw/day ADI as still valid.