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Risk assessment on EU flavours throws up data holes

By staff writer , 24-Oct-2005

Europe's watchdog continues to wade through the risk assessment of 1000 flavouring substances, concluding that seven out of eight in the latest batch need more data to determine 'reliable exposure'.

Following a request from the European Commission, the 18 member panel of scientific experts at the European Food Safety Authority evaluated eight flavouring substances in the Flavouring Group Evaluation FGE.15.

The evaluation dealt with eight aryl-substituted saturated and unsaturated primary alcohol, aldehyde, carboxylic acid and ester derivatives.

Five of the eight flavouring substances in the present group have been reported to occur naturally in a wide range of food items.

"For seven of the eight flavouring substances considered in this opinion the intakes, estimated on the basis of the mTAMDI (modified Theoretical Added Maximum Daily Intake), exceed the relevant threshold for their structural class, to which the flavouring substance has been assigned," concludes EFSA.

The scientists claim that for these seven substances [FL-no: 02.173, 08.088, 08.089, 09.690, 09.735, 09.836, and 09.837] more reliable exposure data are required.

European Parliament and Council Regulation (EC) No 2232/96 sets out the basic rules or the use of flavouring substances in or on foodstuffs in the EU.

It also lays down a procedure for the establishment of an EU-wide positive list of flavouring substances, , that kicked off in July 2000. After its establishment, originally foreseen for the end of 2005, only those flavouring substances listed may be added to foods.

The basic elements to establish the positive list require that the substances authorised for use in foodstuffs at national level have been listed by the Commission in a register of over 1000 substances.

In addition, that the substances are evaluated in accordance with the programme laid down by Commission Regulation (EC) No 1565/2000.

Up until the end of 2002, work was carried out within the framework of scientific co-operation by Member States, in close co-operation with the Commission's Scientific Committee on Food (SCF). From 2003, the job has fallen to scientists at EFSA.

The agency states this week that for its evaluation, the panel of scientists used the Maximised Survey-derived Daily Intakes(MSDIs) approach to estimate per capita intakes of the flavouring substances in Europe.

But the panel warns the flavour industry that when it examined information provided by the European flavouring industry on the use levels in various food "it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the industry, especially in those cases where the annual production values were reported to be small."

As a result, the scientists said they had reservations about the data onuse and use levels provided and the intake estimates obtained by the MSDI approach.

In addition, the EFSA scientists further warned the available "genotoxicity data are not sufficient to evaluate the genotoxicity adequately. " Although it added that the data available on mutagenic and clastogenic activity of both candidate and supportingSubstances, as well as the chemical structures of the candidate substances, "do not give reason for concern with respect to genotoxicity of the eight candidate substances in this flavouring group."

The full evaluation can be accessed on the EFSA site.

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