EFSA adopts three further opinions on flavourings:one substance found to be unacceptable on safety grounds

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) of the European Food Safety Authority (EFSA) published today three further opinions concerning the safety evaluation of 51 flavouring substances. While 13 passed the evaluation process, the Panel advised that more reliable data on exposure are required to carry out the safety evaluation for 37 substances of the 3 flavouring groups assessed. One flavouring substance, pentane-2,4-dione, did not pass the initial steps in the screening process due to safety considerations. The AFC Panel has therefore advised that its use as a flavouring substance is not acceptable on safety grounds. The European Commission has since proposed that this substance be removed from the Register of flavouring substances used in or on foodstuffs to the Standing Committee on Food Chain and Animal Health which has given a favourable opinion.

Within the framework of Community legislation on flavouring substances*, and after having published its first two opinions in November 2004**, EFSA’s AFC Panel proceeded in finalising the safety evaluations for 51 additional flavouring substances***. 13 substances passed the evaluation process. The Panel was unable to carry out a full safety evaluation for the remaining 37 substances due to lack of precise data on their use and usage levels in foods.

One substance in flavouring group 11 (FGE.11), pentane-2,4-dione, was found to be genotoxic (i.e. that it can damage DNA, the genetic material in cells) both in vitro and in vivo. The AFC Panel therefore advised that, based on current evidence, its use as a flavouring substance is not acceptable on safety grounds.

Commenting on the Panel’s conclusions, the Chair of the EFSA Panel, Dr. Sue Barlow explained: “The advice that this flavouring substance should no longer be utilised reflects the Panel’s rigorous approach to information revealing that a substance added to foods has genotoxic potential. However it’s our understanding that its use up to now as an added flavouring substance in foods has been very limited.”

The use of pentane-2,4-dione as an added flavouring substance in foods will disappear now following the Commission’s proposal to remove it from the Register of flavouring substances and subsequent favourable opinion of the Standing Committee on the Food Chain and Animal Health. According to Regulation (EC) No 2232/96, all substances listed in the Register are subject to a safety evaluation procedure following which a positive list of flavouring substances authorised for use in or on foods in the EU shall be adopted.

*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

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

***Flavouring Group Evaluation 7 (FGE.07): Saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group 5
(Commission Regulation (EC) No 1565/2000 of 18 July 2000)

Flavouring Group Evaluation 9 (FGE.09): Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols from chemical group 8 or a phenol carboxylic acid from chemical group 25

Flavouring Group Evaluation 11 (FGE.11): Aliphatic dialcohols, diketones, and hydroxyketones from chemical group 10 (Commission Regulation (EC) No 1565/2000 of 18 July 2000) 

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