Lycopene: EFSA and JECFA disagree on rat liver findings
What it found
Two expert bodies looked at the same one-year rat study and reached different conclusions about lycopene.
EFSA set an acceptable daily intake of 0.5 mg/kg body weight per day; JECFA set no specified limit.
What they found
Animal and lab studies
EFSA's daily limit
EFSA's panel set an acceptable daily intake of 0.5 mg/kg body weight per day. This was based on a level of 50 mg/kg body weight per day in a one-year rat study, where no harmful effects were seen.
Liver enzyme changes in rats
The one-year rat study showed a non-reversible increase in alanine transaminase (ALT) activity at the higher dose. JECFA also described effects on aspartate transaminase (AST) and ALT activities.
Extra rat study
JECFA also looked at an additional 28-day rat study, which found a level of 200 mg/kg body weight per day with no harmful effects. The panel said this study was not the reason for the different conclusions.
Other findings
JECFA's different limit
In 2009 JECFA replaced its group acceptable daily intake of 0-0.5 mg/kg body weight with a group acceptable daily intake "not specified" for lycopene from all sources.
Reason for disagreement
The panel concluded that the two bodies disagreed not because of new data, but because they interpreted the liver enzyme effects in the one-year rat study differently.
What the authors conclude
“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.”
Also in their conclusions
- They agree with the earlier EFSA evaluation of the one-year rat study and the level of 50 mg/kg body weight per day identified from it.
- They say the divergence of scientific opinions is not based on data that were not available to EFSA, 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.
How it was done
The European Commission asked EFSA's panel to explain why its lycopene risk assessment differed from JECFA's.
The panel compared its own 2008 evaluation of lycopene with JECFA's 2009 evaluation. Both looked at the same one-year rat study and a 28-day rat study.
What it can’t tell you
- We summarised it from the abstract only.
- This statement compares two risk assessments; it does not present new studies in people.
- The rat studies can show liver enzyme changes in rats, but they cannot show what happens in people.
The paper
- Title
- Statement on the divergence between the risk assessment of lycopene by EFSA and the Joint FAO/WHO Expert Committee on Food Additives (JECFA)
- Type
- Scientific opinion of the European Food Safety Authority
- Evidence
- Animals and lab studies
- Summarised from
- Abstract only
- Cite
- EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) (2010). Statement on the divergence between the risk assessment of lycopene by EFSA and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2010.1676Free full textPubMed 42005766DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error