Statement on the divergence between the risk assessment of lycopene by EFSA and the Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food delivers a statement on the divergence between the risk assessment of lycopene by the European Food Safety Authority (EFSA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The AFC Panel derived an ADI of 0.5 mg/kg bw/day based on a No-Observed-Adverse-Effect Level (NOAEL) of 50 mg/kg bw/day from a one-year rat study and a non-reversible increase in serum alanine transaminase (ALT) activity. In 2009 JECFA replaced the group ADI of 0-0.5 mg/kg bw with a group ADI “not specified” for lycopene from all sources. The JECFA evaluation also included the one-year rat study and described the effects on aspartate transaminase (AST) and ALT activities. The Panel noted that the evaluation by JECFA only provides a very limited rationale for disregarding the effects on ALT and AST in the one year rat study. The Panel also noted that compared to the EFSA 2008 evaluation, the JECFA evaluation does take into account an additional 28-day rat study, but since this study reveals a NOAEL of 200 mg/kg bw/day it is not the reason underlying the diverging outcome of the risk assessment. The Panel 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 the one-year rat study. The ANS Panel agrees with the evaluation of the one year rat study by the AFC Panel, and the NOAEL of 50 mg/kg bw/day identified from that study based on a non-reversible increase in alanine transaminase (ALT) at the higher dose level.