EFSA adopts two opinions on flavourings: further intake data required to pursue risk assessments

Within the framework of Commission Regulation (EC) 1565/2000* the European Food Safety Authority (EFSA) is asked to evaluate flavouring substances in order to provide the European Commission with the scientific basis for proposing legislation introducing a list of permitted flavouring substances for use in or on foods. More than 1000 substances need to be evaluated before July 2005. Today EFSA’s Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) has published its first opinions on 77 flavouring substances. The Panel concluded that there is no indication of genotoxic or carcinogenic potential for all of the substances evaluated. All 77 flavouring substances passed the evaluation process when applying the method laid down in legislation and previously utilised by the former Scientific Committee on Food (SCF). However, in carrying out an evaluation of exposure levels among regular consumers of foods containing these flavourings, the Panel considered that, for 33 of these substances, more specific data were required in order to pursue the assessment.

In carrying out its risk assessment on flavourings, the AFC Panel reconsidered the approach to be followed in estimating levels of exposure to these substances in order to more precisely calculate exposure levels among regular consumers of foods containing flavourings. At its plenary meeting in July 2004**, the Panel therefore decided to supplement the stepwise evaluation procedure previously used by the former SCF. This method was based on exposure estimates derived from annual production volumes. In addition, the Panel decided to calculate potential exposure to these flavourings, based on levels added to foods, as reported by industry. This is in line with the SCF view that other exposure estimates might need to be taken into account in the future.

When evaluating the substances in flavouring groups 3 and 6 , the Panel concluded that all 77 substances are not of safety concern at the levels of exposure determined by the method based on production volumes. However, when applying the additional method based on reported use levels in foods, the Panel came to the conclusion that more precise exposure data were required for 33 of the substances concerned. On the basis of such additional data, these flavouring substances will be reconsidered. The request for data at this stage in the procedure does not imply that there is a risk.

*Commission Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council

**The Minutes of the 7th Plenary Meeting of the AFC Panel

***Flavouring Group Evaluation 3 (FGE.03): Acetals of branched- and straight-chain aliphatic saturated primary alcohols and branched- and straight-chain saturated aldehydes, and an orthoester of formic acid, from chemical groups 1 and 2 (Commission Regulation (EC) No 1565/2000 of 18 July 2000)

****Flavouring Group Evaluation 6 (FGE.06): Straight- and branched-chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters from chemical groups 1 and 4 (Commission Regulation (EC) No 1565/2000 of 18 July 2000)

The full text of the opinions:

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