The European Commission asked EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) to re-examine a previous risk assessment on lycopene that had been established by the Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with food (AFC Panel).
In 2008, the AFC Panel had published an opinion on the safety of lycopene, recommending an Acceptable Daily Intake (ADI) of 0.5mg/kg bw/day. This was in line with an ADI established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2006.
However, in 2009, JECFA reviewed its opinion on lycopene, and revised its ADI to ‘not specified’ for lycopene from all sources when used as food colour.
In light of this change, the European Commission asked EFSA to re-examine its own position, and to investigate the reason for the divergence in opinion. Specifically, the Commission requested a statement on whether the revised JECFA opinion was based on new data that had been unavailable to EFSA during its 2008 evaluation.
However, in an opinion published this week, EFSA confirmed its 2008 evaluation, saying that no additional data was examined by JECFA. The difference in opinion was based on “a diverging interpretation of the toxicological relevance” of certain effects noted in a study on lycopene, it said.
EFSA’s 2008 opinion was established based on a one-year rat study, in which elevated serum aspartate transaminase (AST) and alanine transaminase (ALT) levels were seen down to the intermediate dose of 50 mg lycopene/kg bw/day.
Based on observations from this study, 50mg lycopene/kg bw/day was considered the No-Observed-Adverse-Effect Level (NOAEL), where the effects on the AST and ALT levels were considered not toxicologically significant. Using an uncertainty factor of 100, an ADI of 0.5 mg/kg bw/day was established.
The JECFA evaluation also included the one-year rat study on which the EFSA ADI is based and describes the effects on AST and ALT. However, the JECFA evaluation considered the elevated levels of AST and ALT not to be adverse because of the lack of concordance with other important measures usually associated with liver damage, such as increased organ weight and histopathology.
EFSA concluded that “the divergence of scientific opinions is not based on data that were not available to EFSA during its evaluation of lycopene, but rather to a diverging interpretation of the toxicological relevance of the effects seen on AST and ALT levels in a one-year rat study.”
EFSA’s opinion now passes to the European Commission for evaluation.
To view the opinion, click here.