EFSA’s evaluation of the safety of food flavouring substances- an update

The EFSA Panel on additives, flavourings, processing aids and materials in contact with food (AFC) is working on a systematic evaluation of the safety of flavouring substances currently in use in the European Union (EU). A programme for their evaluation is laid down by European Parliament and Council Regulation (EC) N° 2232/96. Informed by this work, the European Commission (EC) will establish a positive list of flavouring substances that will be authorised for use in the EU.

Flavouring substances are used to give taste or smell to food. Food manufacturers have been using flavouring substances for many years in a wide variety of foods, from confectionary and soft drinks to cereals, cakes and yoghurts. The Member States notified about 2,800 flavouring substances that may, in accordance with Directive 88/388/EEC, be used in and on foodstuffs marketed in their territory. These 2,800 flavouring substances have been compiled by the Commission into a register. EFSA has divided these flavouring substances into 48 groups for evaluation. Among flavourings listed in the register there are many substances which occur naturally in animal and vegetable products as well as artificial flavouring substances.

In order to confirm that their use is safe, EFSA scientists are looking at intake levels, absorption, metabolism and toxicity of individual substances in the human body. Whilst undertaking these evaluations, EFSA has in several cases identified data gaps. Where necessary, EFSA is requesting additional information. The type of data missing varies from production volumes to information on toxicity that might require additional research and testing in vitro and in vivo. These data are therefore needed to confirm that the substances are safe when used as flavouring.

Recently one substance, 2-methyl-1,3-butadiene (isoprene), has been identified where there are adequate data to question its safety with any certainty, given its genotoxic potential and carcinogenic effects in experimental animals. Given the available data on possible risks, EFSA finds that isoprene should not go forward for further evaluation.

EFSA aims to complete the evaluations of all the substances in the Register, for which adequate data have been received, by April 2008.