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EFSA assesses safety of lycopene in foods

EFSA was asked to assess the safety of the red food colour lycopene from all food sources, considering both that contained naturally in fruit and vegetables and the use of lycopene as a food additive A substance deliberately added to foods or beverages for beneficial technological reasons (e.g. to preserve, flavour, colour or ensure a particular texture). Food additives are not normally consumed by themselves nor used as typical ingredients in food.. EFSA’s AFC[1] Panel established an Acceptable Daily Intake The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet. ( ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.) for lycopene of 0.5 mg per kilogram of body weight per day from all sources. It however pointed out that high consumers of foods containing lycopene in certain groups of the population Community of humans, animals or plants from the same species., such as pre-school and school children, may exceed the ADI The acceptable daily intake (ADI) is an estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.. Non-alcoholic flavoured drinks are the largest potential source of lycopene. This opinion will also help inform ongoing evaluations by EFSA’s NDA[2] Panel, expected to be adopted in Spring 2008, concerning the use of lycopene as a novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997. ingredient Any substance deliberately added to a foodstuff which will remain in the finished product, even in an altered form..

Previous assessments of lycopene and its consumption in the EU had only taken into account exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to lycopene which had been purposely added to food and did not include naturally occurring lycopene in food, such as that found in tomatoes and other fruits and vegetables. The Panel looked at how much lycopene in total could be safely ingested by consumers. For the majority of consumers, intakes of lycopene from all sources were within the ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. of 0.5 mg per kilo of bodyweight per day (including consumption of naturally-occurring lycopene from sources such as tomatoes). However, the Panel noted that in some cases, the ADI may be exceeded by high consumers of foods containing lycopene in certain groups of the population, such as pre-school and school children.

The Panel concluded that the use of lycopene as a food colour adds significantly to the overall intake of lycopene. Non-alcoholic flavoured drinks are the largest potential source of lycopene in all population groups, contributing up to 66% of all lycopene intake in male adults and more than 90% in pre-school children.

Lycopene is a member of the carotenoid family and occurs naturally in tomatoes (including tomato products, such as ketchups and tomato purees), vegetables and other fruits such as watermelon, pink grapefruit, and papaya. Lycopene is also authorised for use as a food colour (E 160d) and can be added to food and drink products, such as non-alcoholic flavoured drinks, fruit preserves, confectionary, sauces, jams and jellies.

In addition, under the Novel Foods Regulation, EFSA’s NDA Panel is presently carrying out an evaluation of new proposed food uses of lycopene. Two opinions on lycopene oleoresin from tomatoes and synthetic lycopene as novel foods are likely to be adopted by the NDA Panel in Spring 2008.

[1] Panel on additives, flavourings, processing aids and materials in contact with food.
[2] Panel on dietetic products, nutrition The science of how diet relates to the body's need for sustenance. and allergies.