Use of Lycopene as a food colour

Following a request from the Commission, the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food was asked to deliver a scientific opinion on the safety in
use of synthetic lycopene as a food colour for use in the food categories specified in the dossier.

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food has also been asked to evaluate the safety in use of lycopene from Blakeslea trispora as
a food colour in the food categories and use levels as proposed in the dossier.

In addition, in view of the re-evaluation of lycopene from tomatoes within the re-evaluation programme of all food colours, the Panel decided to make a global safety assessment of lycopene from
all sources. Thus, in the present opinion the Panel evaluates the safety in use of lycopene from different sources as a food colour.
Results from animal and human intervention studies with synthetic lycopene or tomato extract as lycopene source indicate that lycopene from these sources is bioavailable. It is expected that
lycopene from B. trispora when used in foodstuffs of comparable composition will be bioavailable to a similar extent as lycopene from tomatoes.

The toxicity of synthetic lycopene was investigated in subchronic and chronic toxicity studies in rats, a carcinogenicity study and a two-generation study in rats, and developmental toxicity
studies in the rat and rabbit. Mutagenicity has been studied in an extensive program using formulated forms of lycopene. The results did not raise a safety concern. The following No Observed
Adverse Effect Levels (NOAELs) for formulated, synthetic lycopene, were established in guideline-conforming toxicity studies:
? 500 mg/kg bw/day (the highest dose level tested) in a 14-week rat study
? 500 mg/kg bw/day (the highest dose level tested) in a developmental toxicity study in the rat
? 500 mg/kg bw/day (the highest dose level tested) in a two-generation study in the rat
? 400 mg/kg bw/day (the highest dose level tested) in a developmental toxicity study in the rabbit
? 50 mg/kg bw/day in a one-year rat study, and
? 50 mg/kg bw/day (the highest dose level tested) in a two-year rat carcinogenicity study.

The NOAEL from a 90-day oral toxicity study with lycopene extracted from B. trispora amounted to about 600 mg/kg bw/day.

The Panel derives an ADI of 0.5 mg/kg bw/day using a safety factor of 100 based on a NOAEL of 50 mg/kg bw/day from a one year rat study and a non-reversible increase in alanine transaminase
(ALT). This ADI refers to lycopene from all sources.

The Panel noted that the ADI set by JECFA does not include lycopene from tomatoes. This was probably due to the fact that JECFA was not evaluating lycopene from tomatoes.

The Panel concludes however that the ADI defined in the present opinion should include lycopene from tomatoes as well, because the toxicological data base contains several toxicity studies on
lycopene from tomatoes showing no adverse effects up to the highest dose levels tested. These studies include a 10-week study in rats, and a 28-week study in mice revealing NOAEL values of
respectively 60 mg/kg bw/day and 35 mg/kg bw/day both being the highest dose levels tested. From this it is concluded that the NOAEL values for these studies with lycopene from tomatoes are in
the same range as the value of 50 mg/kg bw/day from which the ADI is derived, and that therefore the ADI refers to lycopene from all sources.

The Panel noted that total daily exposure to lycopene from B. trispora as a food colour could potentially range from 2 to 6 mg on the average and go up to 11 to 23 mg at the high level.

The Panel does not exclude an occasionally combined high exposure from both natural dietary sources and food colours up to 43 mg of lycopene per day.

The proposed use of lycopene as a novel food ingredient is not taken into account, because this is not in the remit of the AFC Panel but in the remit of the NDA Panel.

The use levels used in these calculations were generally 40-90% lower than the maximum use-levels permitted for food colours, including lycopene extracted from tomatoes, under Directive
94/36/EC. These intake estimates of lycopene used as a food colour are based on conservative assumptions and may therefore overestimate potential intake since lycopene is assumed to be present
in all categories where it is authorised.

It is concluded that use of lycopene as a food colour adds significantly to the overall intake of lycopene.

The Panel also concludes that with the uses and use levels presented in the present opinion, which are lower than the maximum use-levels permitted for food colours under Directive 94/36/EC, the
intake of lycopene from natural sources and as a food colour would be expected to remain within the ADI of 0.5 mg/kg bw/day. However, this does not hold for the high level intakes by pre-school
and school children.

The Panel notes that non-alcoholic flavoured drinks were found to be by far the largest potential source in all population groups considered, with percentage contribution of the total
calculated intake of lycopene ranging from 66% in male adults to more than 90% in pre-school children.

The Panel notes that specifications for lycopene from tomatoes may need to be updated taking the actual lycopene content in current colouring preparations into account.

Opinion

1 For citation purposes: Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission on the safety in
use of lycopene as a food colour. The EFSA Journal (2008) 674, 1-61

* 1 member of the Panel did not participate in the discussion on the subject referred to above because of possible conflict with declared interests.