Following a request from the European Commission, an exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for lycopene (E 160d) and the proposed extension of uses in to the categories 08.2 meat preparations as defined by Regulation (EC) No 853/2004, 08.3.1 Non-heat-treated meat products, 08.3.2 Heat-treated-meat products and 04.2.4.1 Fruit and vegetable preparations excluding compote, as proposed by the applicant.
Lycopene (E 160d) is a carotenoid which is currently an authorised food additive (colour) in the European Union (EU) under Annex II Regulation (EC) No 1333/2008 for use in several food categories.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) has already evaluated the toxicological data on lycopene and derived an acceptable daily intake (ADI) of 0.5 mg/kg bw per day using a safety factor of 100. This ADI refers to lycopene from all sources.
In the present opinion, an anticipated exposure to lycopene (E 160d) as a food additive at the maximum permitted levels (MPLs) was undertaken by the European Food Safety Authority (EFSA), by performing a refined exposure assessment, taking into consideration the current authorised uses and the proposed extension of uses as provided by the applicant. For the exposure assessment scenario, 24 out of the 30 currently authorised food categories were taken into account and 28 food categories if both authorised and proposed food categories are considered.
The Panel noted that the mean dietary exposure to lycopene (E 160d) in the total population, considering the current MPLs and the proposed extension of uses and use levels, ranged from 0.01 mg/kg bw per day in infants to 0.82 mg/kg bw per day in toddlers. At the high level, dietary exposure to lycopene (E 160d) ranged from 0.03 mg/kg bw per day in infants to 1.39 mg/kg bw per day in toddlers. The Panel noted that the ADI of 0.5 mg/kg bw per day is exceeded for toddlers and children at the mean and for toddlers, children and adolescents at the p95. At worst, high level exposure is 2.8 times higher than the ADI (toddlers at the high level).
The Panel concluded that the proposed extension of uses of lycopene (E 160d) as a food additive in meat preparations, meat products and fruit and vegetable preparations up to 60 mg/kg would not add significantly to the intake of the food additive at its current MPL. However, the Panel noted that the overall intake at the MPL scenario would exceed the currently established ADI. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) acknowledged the uncertainties in the current estimates which could result in an overestimation of the exposure to lycopene (E 160d) as a food additive in European countries and therefore concluded that a refined exposure estimate would be recommended in order to decrease uncertainties in its current estimates.
The Panel concluded also that exposure estimates calculated for the current assessment are not directly comparable with the previous opinion (EFSA, 2010) owing to the changes in the underlying consumption data and use levels used for the exposure assessment and different methodology applied.