The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to evaluate one flavouring substance in the Flavouring Group Evaluation 309, using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. This flavouring substance belongs to chemical group 01 Annex I of the Commission Regulation (EC) No 1565/2000.
The flavouring substance is sodium diacetate [FL-no: 16.073].
The candidate substance belongs to structural class I and has not been reported to occur naturally in foods.
The substance has not been reported to occur naturally in foods. It does not possess structures which can give rise to stereoisomerism.
In its evaluation, the Panel as a default used the “Maximised Survey-derived Daily Intake” (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavouring Industry on the use levels in various foods, 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. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.
In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a “modified Theoretical Added Maximum Daily Intake” (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Panel requires more precise data on use and use levels.
The estimated daily per capita intake (MSDI) of sodium diacetate [FL-no: 16.073] from use as a flavouring substance is 4000 microgram per person per day.
No concern of genotoxicity has been identified for sodium diacetate.
The metabolism data available were sufficient to conclude that the candidate substance is rapidly absorbed, metabolised to endogenous innocuous products and excreted through normal biological mechanisms.
The former Scientific Committee on Food (SCF) has derived a group Acceptable Daily Intake (ADI) “not specified” for acetic acid and sodium acetate, including sodium diacetate (CEC, 1991). Because of the availability of this ADI, the Panel considered that the application of the Procedure for sodium diacetate is not necessary. The per capita intake estimate (MSDI) of 4000 microgram per person per day is in concordance with the group ADI and no safety concern is identified when sodium diacetate is used as a flavouring substance at the current level of use in the EU.
No use levels are provided for sodium diacetate, therefore no mTAMDI can be calculated. Thus, further information is required. This would include more reliable intake data.
In order to determine whether the conclusion for the candidate substance can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications, including complete purity criteria and identity, for the materials of commerce have been provided for the flavouring substance.
In conclusion, the Panel concluded that sodium diacetate [FL-no: 16.073] would not pose a safety concern when used as a flavouring substance, at the anticipated intake levels based on the MSDI approach.